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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic GEM

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  Class 2 Device Recall Medtronic GEM see related information
Date Initiated by Firm November 14, 2002
Create Date December 02, 2002
Recall Status1 Open3, Classified
Recall Number Z-0308-03
Recall Event ID 25041
Product GEM DR Model 7271 Implantable Cardioverter-Defibrillator (ICD)
Code Information All serial numbers beginning with PIM4. The serial number have the form of PIM4xxxxxx.
Recalling Firm/
Manufacturer		 Medtronic,Inc/Rice Creek Facil
7000 Central Ave N.E.
Fridley 55432
Manufacturer Reason
for Recall		 Extended charge times prior to defibrillation shock.
Action An 'Important Patient Management Information' letter, dated November 14, 2002, was sent to physicians following patients who had the defibrillators implanted and this gave recommendations to physicians to prevent the problem.
Quantity in Commerce 2539 devices
Distribution The devices have been distributed nationwide in the United States and worldwide. 2,151 units have been distributed in the United States, and 387 units have been distributed worldwide outside the U.S.
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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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