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Medtronic SynchroMed Infusion Pump Lawsuit

The Medtronic SynchroMed II drug infusion pump is a medical device that has been linked to reports of accidental drug overdose, underdose, life-threatening withdrawals and at least 14 patient deaths.
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C.L. Mike Schmidt Published by C.L. Mike Schmidt

No-Cost Confidential Legal Review: Should you or someone close to you suffer injuries from a Medtronic pain pump, it’s imperative that you reach out to our legal team without delay. You could be eligible for financial restitution through initiating a Medtronic SynchroMed Infusion Pump Lawsuit against the creator, and our attorneys are ready to assist.

If you or a loved one relies on a Medtronic SynchroMed II implantable drug infusion pump, it’s important to be aware of the serious risks and recalls linked to these devices.

Multiple safety warnings have been issued due to permanent motor stalls, drug delivery malfunctions, and life-threatening complications. These failures can lead to severe withdrawal symptoms, overdoses, or a return of chronic pain and spasticity.

Why Is the SynchroMed II Pump Under Investigation?

The FDA has classified several recalls of the SynchroMed II pump as Class I events, meaning they pose a risk of serious injury or death.

Reports indicate at least 14 patient deaths due to issues like under-delivery, over-delivery, and pump failure. Despite manufacturer warnings, many patients have suffered severe medical consequences, prompting lawsuits against Medtronic for negligence and product liability.

Signs Your Pump May Be Failing

  • Withdrawal symptoms (if receiving intrathecal baclofen)
  • Sudden worsening of pain or spasticity
  • Unexplained drug side effects or overdose symptoms
  • Pump alarms signaling a malfunction

What You Can Do

  1. Check Your Device Model – Verify if your SynchroMed II pump (Models 8637-20 or 8637-40) is affected by a recall.
  2. Monitor for Symptoms – Be aware of withdrawal signs, pain spikes, or unusual drug reactions.
  3. Consult Your Doctor Immediately – Discuss concerns, possible device failures, and legal options.

If you or a loved one has suffered severe complications due to a Medtronic SynchroMed II pump, you may be eligible for financial compensation.

Lawsuits are being filed against Medtronic, alleging design defects, failure to warn patients, and negligence in addressing known safety issues. Contact an attorney today to explore your legal options.

Synchromed Pain Pump

What is the SynchroMed II Pump?

The Medtronic SynchroMed II infusion pump, commonly known as a pain pump, is a surgically implanted device that uses a catheter to deliver pain medication directly into an area near the patient’s spinal cord.

Inserted just under the skin, the pump is used to treat patients with primary or metastatic cancer, severe muscle spasms, pain, and other serious health conditions.

The SynchroMed II was approved by the U.S. Food and Drug Administration (FDA) in 2004, and there are currently about 270,000 of the pumps on the market.

Similar Article: Alaris Infusion Pump Recall Lawsuit

Medtronic SynchroMed II Pump Recall Timeline: Key Failures and Risks

Since the approval of the Medtronic Infusion Pump System, over 30 Class I recalls have been issued due to mechanical failures, battery defects, design flaws, and motor stalls.

These issues have resulted in serious injuries, life-threatening withdrawal symptoms, and fatalities. Below is a breakdown of the major recalls and warnings grouped by issue type.

Mechanical Failures: Malfunctions That Disrupted Drug Delivery

Mechanical defects have caused over- and under-infusion of medication, device failure, and delays in therapy, putting patients at risk.

  • 2006 – Manufacturing defects led to unpredictable drug delivery, increasing the risk of severe withdrawal symptoms.
  • August 2007 – Class I recall for SynchroMed EL pumps due to high stall rates in motors produced before September 1999.
  • July 17, 2012 – The FDA issued a warning letter about motor corrosion and medication delivery failures, raising concerns about the long-term reliability of the pumps.

These failures made drug administration unreliable, leading to dangerous fluctuations in medication levels.

Battery Failures: Unexpected Shutdowns and Medication Interruptions

Battery defects in the SynchroMed II pumps have caused sudden device failures, preventing patients from receiving critical medications.

  • January 2009 – Medtronic issued a warning about battery depletion, which could cause the pump to shut down and release incorrect medication doses.
  • July 2011 – The SynchroMed II faced a Class I recall due to unresolved battery problems previously flagged by the company.

Battery failures left many patients vulnerable to withdrawal symptoms or overdoses, particularly those relying on intrathecal baclofen for spasticity treatment.

Design Flaws: “Pocket Fill” Errors Leading to Dangerous Overdoses

A major flaw in the pump’s refill design led to accidental overdoses when medication was injected into surrounding tissue instead of the pump reservoir.

  • January/February 2011 – The FDA issued multiple warnings about the risk of “pocket fill” errors, causing immediate overdoses of pain medication or baclofen.

This design issue significantly increased the risk of respiratory failure, unconsciousness, or death when incorrect dosing occurred.

Foreign Particles and Motor Stalls: Leading Cause of Device Failure

Tiny particles inside the pump have led to permanent motor stalls, completely stopping drug delivery.

  • October/December 2019 – Medtronic issued a Class I recall for the SynchroMed II pump due to foreign particle contamination inside the motor assembly, which could cause immediate drug delivery failure.

Motor stalls have been one of the leading causes of pump failure, leaving patients without essential medication and increasing withdrawal risks.

Electromagnetic Interference (EMI) & MRI-Related Issues

Exposure to MRI scans and electromagnetic fields caused delays in drug infusion, leading to concerns about the device’s safety in medical environments.

  • 2008/2009 – Reports emerged about delayed drug infusion after MRI scans, raising concerns about device reliability, though no serious injuries were reported.

Patients with the SynchroMed II pump must take precautions when undergoing MRI scans to avoid unexpected interruptions in therapy.

If you or a loved one has suffered complications from a SynchroMed II pump, legal options may be available to seek compensation for medical harm and financial losses.

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Serious Complications of the Medtronic SynchroMed II Pump

While the Medtronic SynchroMed II pump is designed to provide targeted drug delivery for chronic pain and spasticity, device malfunctions and complications have led to severe health risks, life-threatening emergencies, and even fatalities.

Below is a breakdown of immediate dangers, long-term risks, and warning signs that all users should be aware of.

Immediate Life-Threatening Risks

When the pump malfunctions, it can deliver too much or too little medication, leading to serious complications that require immediate intervention.

  • Overdose – The pump may release too much medication due to malfunctions or programming errors, potentially causing respiratory depression, confusion, or coma.
  • Underdose – If the pump fails to deliver enough medication due to catheter blockages or mechanical failure, patients can experience severe withdrawal symptoms.
  • Withdrawal Symptoms – Sudden drops in medication levels can be life-threatening, particularly for patients using intrathecal baclofen for spasticity management. These symptoms include muscle rigidity, hallucinations, seizures, and fever.

Patients and caregivers must monitor for sudden changes in symptoms and respond quickly to pump alarms or unusual medication effects.

Long-Term Complications and Device Failures

Beyond immediate risks, long-term issues with the pump or catheter system can cause ongoing medical problems and require surgical intervention.

  • Infection & Device Erosion – Infections at the implant site occur in 15.7% of adverse reports, increasing the risk of device rejection or deep tissue damage.
  • Catheter Malfunction – Blockages, kinks, or disconnections in the catheter system disrupt drug flow, leading to withdrawal symptoms and pain flare-ups. Catheter-related issues are among the most common failures in these pumps.
  • Pump Failure & Motor Stalls – 12.4% of reported pump malfunctions involve motor stalls or component breakdowns, requiring surgical removal or replacement.

Regular device monitoring and medical check-ups can help detect early signs of failure, reducing the risk of severe complications.

Recognizing Warning Signs and Emergency Symptoms

Early detection of pump malfunctions can prevent serious health risks.

Patients should watch for:

  • Sudden worsening of pain or spasticity
  • Redness, swelling, or tenderness at the implant site
  • Hearing the pump alarm
  • Dizziness, confusion, or extreme drowsiness

Emergency Symptoms Requiring Immediate Medical Attention

Some complications can quickly escalate to life-threatening emergencies.

Seek urgent care if you experience:

  • Respiratory depression (slow or stopped breathing)
  • Severe confusion or hallucinations
  • Coma or loss of consciousness

The Serious Consequences of Pump Malfunctions

At least 14 deaths have been directly linked to SynchroMed II pump failures, primarily due to withdrawal symptoms, overdoses, and undetected malfunctions. Despite these risks, Medtronic has continued advising against proactive device removal unless medically necessary.

For patients relying on intrathecal drug therapy, understanding these complications and taking proactive steps—such as regular check-ups, recognizing symptoms, and responding to pump alarms—can be the difference between safe treatment and a medical emergency.

Check out our website to find out which medical device lawsuits our lawyers are currently accepting.

According to the Wall Street Journal, on April 27, 2015, federal authorities reached a proposed consent agreement with Medtronic for failing to correct violations with its SynchroMed Pump. [1]

The U.S. Justice Department, working with the FDA, filed the decree along with a complaint alleging that Medtronic and 2 of its executives — Chairman and Chief Executive S. Omar Ishrak and Senior Vice President Thomas M. Tefft — distributed ‘adulterated’ medical devices.

According to the complaint, the infusion pumps weren’t produced by current manufacturing standards.

As part of the proposed decree, Medtronic has agreed to stop manufacturing and distributing the SynchroMed II pump except in rare cases, such as when a doctor certifies that the device is medically necessary.

The company won’t be allowed to resume openly distributing the SynchroMed II until it gets permission from the FDA.

Authorities contend that Medtronic repeatedly failed to correct violations of FDA quality standards. Between 2006 and 2013, FDA investigators conducted 5 inspections of Medtronic’s Neuromodulation facilities in Columbia Heights, Minnesota.

We expect doctors to make medical decisions based on what is best for their patients, not what is best for their bank accounts – said U.S. Attorney Ron Parsons for the District of South Dakota.

The inspections uncovered ‘significant violations,’ including those related to complaint handling, and corrective and preventive actions.

Such measures are intended to ensure that a pump malfunction leading to significant injury or death gets investigated and that changes are made as a result.

According to the US Department of Justice, Minnesota-based medical device maker Medtronic USA Inc. has agreed to pay $8.1 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce a South Dakota neurosurgeon to use certain Medtronic products. [2]

See Other Medtronic Lawsuits We’ve Taken On:

Lawsuit Alleges Synchromed ii Infusion Pump Failure

A U.S. District Judge has denied Medtronic’s motion to dismiss a lawsuit filed by a 70-year-old West Virginia man who claims that the SynchroMed II infusion pump is defective and that Medtronic was negligent in designing it.

Plaintiff John David Brumfield alleges that the pain pump he had implanted in 2012 to treat back pain stopped delivering the pain medication hydromorphone in 2018.

Brumfield went to the emergency room in Sept. 2018 complaining of severe muscle and joint pain, chills, sweats, anxiety, depression, and diarrhea.

His doctor recommended replacing the device and the surgeon found that its motor had stalled, according to the lawsuit. Brumfield sued Medtronic in 2020 and the company subsequently filed for dismissal.

How to Check If Your Medtronic SynchroMed II Pump Is Affected by a Recall

Before filing a lawsuit, it is important to determine whether your Medtronic SynchroMed II pump has been recalled due to safety concerns.

Identifying a recalled device strengthens your legal claim and helps you take proactive steps to protect your health.

Steps to Verify If Your Pump Has Been Recalled

  1. Check Your Device Model – Compare your pump’s model number with the FDA recall list to see if it has been flagged for safety issues.
  2. Speak with Your Doctor – A healthcare provider can inspect your pump, evaluate its function, and monitor for potential failure signs.
  3. Visit the FDA Recall Database – The FDA regularly updates its recall database, where you can find the latest information on defective medical devices.

If your pump is included in a recall, document any symptoms, failures, or malfunctions you have experienced. This evidence is crucial when pursuing a lawsuit against Medtronic for product liability and medical harm.

Exploring Safer Alternatives: What Are Your Options?

If your SynchroMed II pump is failing or recalled, you may need to explore alternative treatment options. Switching to a safer system can help prevent severe complications such as withdrawal symptoms, overdoses, and pump malfunctions.

Alternative Treatment Options

  • Newer Implantable Drug Pumps – Some updated models have improved safety records and reduced failure rates.
  • External Infusion Pumps – These eliminate implantation risks while still delivering controlled medication doses.
  • Oral Medications – In certain cases, oral pain management alternatives can replace infusion therapy, depending on the medical condition.

If you are experiencing complications with your pump, discuss these alternatives with your doctor to ensure a safer and more effective treatment plan.

Taking proactive steps now can protect your health and improve your quality of life while pursuing legal action for any damages caused by Medtronic’s defective device.

Filing a Lawsuit for Medtronic SynchroMed II Pump Injuries

If you or a loved one has suffered serious complications from a Medtronic SynchroMed II infusion pump, you may be eligible to file a lawsuit for medical harm, financial damages, and pain and suffering.

Patients have reported device malfunctions, withdrawal symptoms, overdoses, and even fatalities, leading to legal action against Medtronic.

Below is essential information on eligibility, deadlines, settlement expectations, and steps to take if your pump is part of a recall.

How Long Do You Have to File?

Every state has a time limit for filing a lawsuit, known as the statute of limitations. Missing this deadline could prevent you from pursuing compensation.

  • Ohio: Victims have two years from the date of injury to file a claim.
  • Indiana: Under the Product Liability Act, lawsuits must be filed within two years.

Since legal deadlines vary, speaking with an attorney as soon as possible ensures you don’t miss your opportunity to file.

Average Settlement Amounts

The compensation awarded in Medtronic SynchroMed II lawsuits depends on factors such as the severity of injury, medical expenses, and legal precedent.

  • While exact settlement amounts for SynchroMed II cases are undisclosed, Medtronic has previously paid $8.1 million in settlements for other product-related claims.
  • Patients suffering from severe complications, hospitalizations, or wrongful death often receive higher settlements or jury verdicts.

An attorney can help estimate the potential value of your case based on similar claims and legal outcomes.

How Long Does the Legal Process Take?

Lawsuits against medical device manufacturers can take anywhere from several months to multiple years, depending on the complexity of the case and whether a settlement is reached before trial.

  • Simple cases may be resolved within a year if settled out of court.
  • Complex cases involving multiple plaintiffs or extensive medical evidence may take several years.

Filing sooner increases the chances of securing compensation faster and helps preserve crucial evidence.

FAQs

Can I file a lawsuit if I’ve been harmed by a Medtronic SynchroMed Infusion Pump?

Yes, if you’ve been harmed by a defect or malfunction of the Medtronic SynchroMed Infusion Pump, you may be eligible to file a lawsuit. Legal claims can seek compensation for medical expenses, pain and suffering, lost wages, and other related damages.

What should I do if I suspect my Medtronic SynchroMed Infusion Pump is malfunctioning?

If you suspect your pump is malfunctioning, contact your healthcare provider immediately. They may need to perform diagnostic tests, adjust the device settings, or replace the pump. In case of severe symptoms, seek emergency medical care.

Are there any recalls or safety warnings related to the Medtronic SynchroMed Infusion Pump?

Yes, there have been recalls and safety warnings related to the SynchroMed Infusion Pump due to various issues, including software malfunctions, battery defects, and catheter problems. Check with the FDA or your healthcare provider to see if your device is affected.

What compensation might be available in a lawsuit related to the SynchroMed Infusion Pump?

Compensation may include coverage for medical treatments, surgeries to repair or replace the pump, pain and suffering, lost income due to the inability to work, and in some cases, punitive damages if negligence is proven.

Get a Free Medtronic SynchroMed Infusion Pump Lawsuit Evaluation With Our Lawyers

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers at Schmidt & Clark, LLP that focus on the representation of plaintiffs in Medtronic Infusion Pump lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.

Again, if you or a loved one was injured by the Medtronic SynchroMed II Infusion Pump, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our law firm can help.

Reference:

  1. https://www.wsj.com/articles/medtronic-in-fda-consent-decree-over-its-synchromed-infusion-pump-1430166773
  2. https://www.justice.gov/opa/pr/medtronic-pay-over-92-million-settle-allegations-improper-payments-south-dakota-neurosurgeon

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