Medtronic Sprint Fidelis Recall: How to Get the Answers You Need

Medtronic Recall What To Do Defective Products

Medtronic Sprint Fidelis Recall: How to Get the Answers You Need

Medtronic’s October 15, 2007 recall of their Sprint Fidelis defibrillator lead has many patients scrambling to see their doctors and find out as much information as possible. Many patients have reported not being able to find enough information about their device and have reported feeling frustrated in dealing with doctors and the company itself. Here is some information on how to get the answers you need.
How to find your Sprint Fidelis model number
The model numbers in question are 6930, 6931, 6948 and 6949. Patients should have received an ID card with that information. If you don’t have it, contact the doctor that implanted the device or Medtronics at 1-800-551-5544, ext. 41835 (for patients) or 1-800-723-4636 (for doctors, but we called and were helped at this number.)
Links to information that Medtronic released
Medtronic released several documents and letters related to their October 15th recall of the Sprint Fidelis – some to patients, some to doctors and some to the news media. Unfortunately, many patients and doctors have reported not receiving this information, which is likely as 235,000 patients have had the lead implanted over the past three years.
Patients may want to print out the letter intended for them (see link below) AND the information sent to doctors (see link below) for their own file and their doctor’s file in case he or she doesn’t have it.
Click here for patient, physician and media information: (scroll through to find information on Sprint Fidelis recall.)
Links to FDA information
The Food & Drug Administration (FDA) has also released information on the recall that might be helpful to consumers and a document with common consumer questions and answers about the Medtronic defibrillators and leads. Consumers can access that information at:
Recall information:
hhttp://www.fda.gov/bbs/topics/NEWS/2007/NEW01724.html
Common consumer questions about Medtronic defibrillators and leads:
http://www.fda.gov/consumer/updates/medtronic101507.html
AttorneyPages.com Medtronic Recall Articles
When all else fails
When all else fails, patients are not without recourse. If you can’t get anywhere with your doctor, Medtronic or your insurance company, consider the following options:
Speak with a supervisor. This applies to all three categories above. The squeaky wheel often gets the grease. It’s important to be polite, but firm and persistent, in order to get the information you need.
File a complaint. Consumers have many avenues in which to file a complaint including the American Medical Association (http://www.ama-assn.org/), their state’s insurance department (the National Association of Insurance Commissioner’s has links to every state’s insurance department at http://www.naic.org/), the Better Business Bureau (www.bbb.org/) or the FDA (the FDA site has contact information in every state at: http://www.fda.gov/opacom/backgrounders/complain.html.)
Contact an attorney. An attorney can obtain needed information through negotiations or by filing a lawsuit. To contact an attorney who specifically deals with Medtronic’s Sprint Fidelis recall, click here.

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