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U.S. Department of Health and Human Services

Class 2 Device Recall Model KVDD 901 Implantable Pulse Generator

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  Class 2 Device Recall Model KVDD 901 Implantable Pulse Generator see related information
Date Initiated by Firm May 14, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 03, 2005
Recall Number Z-1110-04
Recall Event ID 29392
PMA Number P980035/014 
Product Classification Implantable Pacemaker Pulse-Generator - Product Code DXY
Product Kappa Model 901 Implantable Pulse Generators (IPGs) are pacemaker devices that provide therapies for bradycardia (slow heart rhythm). Model 901 KVDD IPGs provide atrial sensing and do not provide atrial pacing by design intent; these devices provide ventricular sensing and ventricular pacing; also by design.
Code Information serial numbers:PLE100772H, PLE100708H, PLE100832H, PLE721316S, PLE721730S,  PLE722475S, PLE722599S, PLE722786S, PLE721384S, PLE722723S, PLE723479S, PLE723562S, PLE722865S, PLE722865S, PLE723451S, PLE721760S, PLE721309S, PLE723579S, PLE723754S, PLE722993S, and PLE723183S     
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Managment
7000 Central Ave Ne
Fridley MN 55432
Manufacturer Reason
for Recall		 Potential problems with the programmer interface.
FDA Determined
Cause 2		 Other
Action A letter will be sent to the physicians that correspond to the affected serial numbers. A Medtronic technician will meet with the physician and the patient for implanted units.
Quantity in Commerce 28
Distribution Within the United States and to Europe.
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 = DXY and Original Applicant = MEDTRONIC Inc.
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