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Medical Device Recalls
Class 1 Recall: Micro Jewel II and GEM DR ICDs
See Related Information
Date Recall
Initiated:
 April 4, 2004
Product:
 Micro Jewell II Model 7223Cx and GEM DR Model 7271 Implantable Cardioverter Defibrillators (ICD).
Use:
 Implantable cardioverter defibrillators are mechanical devices used to shock the heart into normal rhythm after patients suffer ventricular tachycardia (rapid heart beat) or ventricular fibrillation (irregular rhythm of the ventricles). The devices are surgically implanted in the chest in a minor procedure lasting less than one hour.
Recalling Firm:
 Medtronic Inc. Cardiac Rhythm Management
7000 Central Ave. N.E.
Minneapolis, Minnesota 55432-5604
Reason for Recall:
 Some Medtronic ICDs were found to have defective high voltage capacitors. As a result, when a cardiac arrhythmia requiring a cardioversion or defibrillation shock occurs, the capacitors may take longer than normal to charge near the end of the battery service life that could cause a delay in delivery or a non-delivery of shock therapy. Such a delay or non-delivery could result in patient injury or death because patients are not receiving the appropriate therapy in time.
Public Contact:
 Tim Samsel
Vice President Cardiac Rhythm Management Regulatory Affairs
763-514-3149
FDA District:
 Minneapolis
FDA Comment:
 Patients with Medtronic ICDs with these model numbers should contact their physicians for further information and advice. Class I 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.
 

For additional information on this product recall, see the Medtronic, Inc. press release at: http://www.fda.gov/oc/po/firmrecalls/medtronic04_04.html

For additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00845.html. Scroll down to “Recalls and Field Corrections: Devices – Class I”.

Updated May 5, 2004

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