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U.S. Department of Health and Human Services

Class 1 Device Recall Medtronic GEM DR

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  Class 1 Device Recall Medtronic GEM DR see related information
Date Initiated by Firm April 02, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 29, 2005
Recall Number Z-0812-04
Recall Event ID 28798
PMA Number P980016 
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Medtronic GEM DR Implantable Cardioverter Defibrillators, Model 7271
Code Information Manufacturing Dates from May 1997 to August 1998; and  Use Before Dates from November 1998 to February 2000.  
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave N.E.
Fridley MN 55432
For Additional Information Contact Tim Samsel
763-514-3149
Manufacturer Reason
for Recall		 Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.
FDA Determined
Cause 2		 Other
Action A letter, dated April 2004, was sent on April 5, 2004 to physicians following patients who had the defibrillators implanted. The letter gave recommendations to physicians for selective replacement of some of the implanted devices and for avoiding the problem. Physicians are being visited by sales representatives to verify notification.
Quantity in Commerce 250 units (34 units in the United States)
Distribution Nationwide in the United States and worldwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Original Applicant = Medtronic, Inc.
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