Class 1 Recall: Medtronic Inc. Sprint Fidelis® Defibrillator Leads

October 15, 2007

Medtronic Inc. Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007.

Leads are thin wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that are used to treat abnormal heart rhythms that can cause the heart to stop suddenly.

These leads are being recalled because a small number of fractures have been detected. When the lead breaks (fractures), it may cause inappropriate shocks or result in a loss of therapy, such as pacing or shocking.

Medtronic has advised doctors to stop implanting these leads and to return unused products to the firm.

Patients who are implanted with this lead or do not know the model of their lead, should contact their physicians for further information.

Patients can read additional FDA Information related to this recall by visiting:

• Questions and Answers for Consumers about Medtronic Recalls Sprint Fidelis Cardiac Leads http://www.fda.gov/consumer/updates/medtronic101507.html
• Statement on Medtronic’s Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads http://www.fda.gov/bbs/topics/NEWS/2007/NEW01724.html

For more information about this recall, please see the company’s press release at: http://www.medtronic.com/fidelis

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

• Online:www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
  Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• FAX: 1-800-FDA-0178