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How do I know if I have a Sprint Fidelis lead?

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Posted in: Sprint Fidelis

You may have a patient card that identifies the implanted devices you have. If you have any uncertainty about your devices, you should contact your physician.

Does this action affect other Medtronic devices?

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Posted in: Sprint Fidelis

This action does not affect patients who have Medtronic devices that are pacemakers. While defibrillators keep the heart from going too fast, pacemakers keep the heart from going too slowly. This action also does not affect patients who have Medtronic ICDs or CRT-Ds without a Sprint Fidelis lead.

What is a medical device recall?

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Posted in: Sprint Fidelis

A recall is an action taken when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A recall for an implantable medical device does not always mean that the device has to be removed.

Why are the Sprint Fidelis Leads being recalled?

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The devices are being recalled because of the potential for lead fractures. These electronic wires are prone to fracture in a small number of patients. This could cause the defibrillator to deliver unnecessary shock or to not operate at all.  Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis lead may have been a possible or likely contributing factor.

How many people have had the Sprint Fidelis lead implanted?

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Posted in: Sprint Fidelis

As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide, including 172,000 Sprint Fidelis leads implanted in the United States.

What should patients do if they have had a Sprint Fidelis lead implanted?

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Posted in: Sprint Fidelis

  • Patients who have had the Sprint Fidelis lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.
  • Patients should not routinely seek removal of the device. The risks of removal in most patients exceed the small risk of lead fractures. Therefore, it is generally recommended to leave functioning leads in place. There are two alternatives to removing the lead. One is to continue using the lead while monitoring closely for signs of fracture. A second is to surgically add a replacement lead. Adding a replacement lead does not require removing the Sprint Fidelis lead. If the Sprint Fidelis is left in a patient without being used, it must be “capped”, which means covering the tip with a small plastic insulation.

Pot Pie Recall Expanded to All ConAgra Brands

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Posted in: Pot Pie Recall

Minnesota agriculture and health officials have expanded the Banquet pot pie recall to include all varieties of ConAgra frozen pot pies. A consumer warning was issued Oct. 9 alerting the public of possible salmonella contamination in Banquet pot pies.

Six Minnesotans have become sick with salmonella bacteria infections after eating Banquet pot pies. The Minnesota cases are part of a multi-state outbreak of salmonella infections. At least 174 cases have been confirmed in 32 states.

All varieties of the of pot pie products under the following brands are part of the expanded recall:

  • Banquet
  • Albertson’s
  • Food Lion
  • Great Value
  • Hill Country Fare
  • Kirkwood
  • Kroger
  • Meijer
  • Western Family

These recalled frozen pot pies include all varieties in 7 oz. single serving packages bearing an establishment number “P-9” or “Est. 1059” printed on the side of the package.

Brands sold in Minnesota include Great Value pot pies (sold at Wal-Mart stores), Kirkwood pot pies (sold at Aldi stores), and Banquet pot pies (sold in a variety of grocery stores and convenience stores). Consumers who have any of the recalled brands of pot pies should not eat them, but instead throw them away.

Infections with Salmonella bacteria can cause diarrhea, fever, abdominal cramping, and vomiting. Symptoms usually last less than a week, but the infection can cause more serious health effects in very young children, the elderly and those with weakened immune systems.

ConAgra announces voluntary pot pie recall

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ConAgra foods announced Thursday, Oct. 11, that it is voluntarily recalling all Banquet brand frozen pot pies and all pot pies marketed under a variety of names, including Wal-Mart’s Great Value brand.Local retailers Wal-Mart and Patricia’s had already removed the product from their shelves by the time of yesterday’s announcement from ConAgra.

Wal-Mart store representatives said they sell 100 to 200 pot pies each week under the Banquet brands and under the Great Value brand.

Patricia’s declined to provide specific sales information, but said they carry three other brands of pot pies unaffected by the recall.

At press time today, the pot pie production line at the Marshall facility, normally running three shifts a day and involving about 80 workers, remains in shutdown.

ConAgra spokesperson Melissa Baron said the Marshall facility employs approximately 650 workers and that there is other work for the temporarily displaced workers to do, if they wish. They can also take a voluntary unpaid leave.

Baron said ConAgra is “erring on the side of caution” in the recall, but hopes to be back in production soon. She emphasized ConAgra makes several other products in another part of the factory and that those products are not affected by the current production halt.

Investigation into a salmonella outbreak in more than 30 states started Oct. 3., and by Monday, Oct. 8, investigators from the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) were inspecting the Marshall facility.

As the inspection continues, consumers are advised not to eat the product.

ConAgra voluntarily included all pot pies in the recall, in an effort to simplify both the recall and the return. Earlier, consumers were told to watch for the code P9 on the product box, but that is no longer necessary, according to Baron.

Baron said consumers should discard the product and either return the empty box to the retailer where they purchased it, or send the side panel of the package to ConAgra Foods, Dept. BQPP, P.O. Box 3768, Omaha, NE 68103-0768. In either case, the purchase price will be refunded.

The recall includes all Banquet pot pie varieties, including poultry and beef. The store brand not-ready-to-eat pot pie products include all varieties under the following brand names:

– Albertson’s (sold at Albertson’s);

– Hill Country Fare (sold at HEB);

– Food Lion (sold at Food Lion);

– Great Value (sold at Wal-Mart);

– Kirkwood (sold at Aldi);

– Kroger (sold at Kroger);

– Meijer (sold at Meijer);

– Western Family (now discontinued; previously sold at a variety stores).

Frozen Pot Pie Recall Announced

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Posted in: Pot Pie Recall

A frozen pot pie producer is recalling all of its pot pie varieties because they may be linked to a salmonella outbreak.

The chicken, turkey and beef pot pies in question were distributed by ConAgra Foods based in Marshall, Missouri. The pies were sold under the brand names of Banquet, Albertson’s, Food Lion, Great Value, Hill Country Fare, Kirkwood, Kroger, Meijer and Western Family. The recall includes all varieties of frozen pot pies in 7 ounce, single serving packages with the numbers P-9 or Est. 1059 printed on the package’s side.

Consumers are urged to check their freezers for the recalled products. People are being told to not eat the pot pies and to discard them.

Salmonella outbreak sparks pot pie recall

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Posted in: Pot Pie Recall

Banquet-brand and store-brand pot pies have been pulled from the shelves of retailers following an announcement some of the items may be contaminated with salmonella.

All varieties of Banquet-brand poultry and beef pot pies have been pulled from freezers at markets and other grocery stores. Store-brand pot pies at Wal-Mart, sold under the Great Value label, also have been pulled.

The initial advisory announced Tuesday by ConAgra Foods, the parent company to Banquet and its store brands, affected only the turkey and chicken varieties with the code “p-9” printed on its side panel. Officials at stores said Friday the products were pulled immediately when the recall was announced.

A full recall of all varieties of poultry and beef pot pies under those brand names was issued Thursday, prompting store officials to pull remaining pies.

Officials at Glen’s, Wal-Mart and Save-A-Lot all said customers who have purchased these products may return them for a full refund. ConAgra Foods asks consumers to first discard the product before returning the package.

All products affected are sold not-ready-to-eat. ConAgra Foods, according to a Thursday press release, will revise on-package cooking directions to provide clearer preparation instructions.

According to Thursday’s press release, ConAgra foods was contacted by health officials regarding concerns some of its Banquet poultry pot pies may be linked to an outbreak of salmonella. Ensuing steps resulted in the removal of pot pies from shelves, suspension of pot pie production at its Marshall, Mo. plant and advising of consumers not to eat these products while an investigation is conducted. The Center for Disease Control and Prevention (CDCP) Web site associates Banquet pot pies with at least 165 cases of salmonella infections in 31 states since Jan. 1. At least 30 people have required hospitalization. Three cases of salmonella have been reported in Michigan.

No deaths have been reported.

According to the CDCP Web site, the illness usually lasts four to seven days and produces symptoms including diarrhea, fever and abdominal cramps. Infants, elderly persons and people with impaired immune systems are more likely to experience serious symptoms.

 

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