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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Virtuoso VR

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  Class 2 Device Recall Medtronic Virtuoso VR see related information
Date Initiated by Firm September 09, 2009
Date Posted November 09, 2009
Recall Status1 Terminated 3 on May 29, 2012
Recall Number Z-0129-2010
Recall Event ID 53294
PMA Number P980016S062 
Product Classification dual chamber ICDS - Product Code LWS
Product Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure.
Code Information serial numbers: PUN400013H, PUN400015H, PUN400016H, PUN400034H,  PUN400036H, PUN400039H, PUN402922H, PUN402926H, PUN415316H,  PUN416223H. 
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact
763-514-4000
Manufacturer Reason
for Recall
A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionalit
FDA Determined
Cause 2
Nonconforming Material/Component
Action An "Important Medical Device Information" letter, dated September 2009 was hand delivered by Medtronic Representatives beginning 09/09/09. The letter describes the issue, identifies affected devices and provides recommendations for patients with devices in the affected subset.. A Patient letter was mailed to patients beginning 09/28/09. For additional information: Doctors are advised to contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636; Device tracking managers are advised to contact your Medtronic representative, or the Patient Registration Department at 1-800-328-2518 x41832; and Patients are advised to contact Medtronic Patient Services number at 800-551-5544 ext. 41835.
Quantity in Commerce 10
Distribution Worldwide distribution (except Idaho and Wyoming) including countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Norway, Portugal, Saudi Arabi, Spain, Sweden, Switzerland, Turkey and United Kingdom.
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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