Date Initiated by Firm | July 27, 2009 |
Date Posted | August 18, 2009 |
Recall Status1 |
Terminated 3 on May 31, 2012 |
Recall Number | Z-1953-2009 |
Recall Event ID |
52853 |
PMA Number | P980016S062 |
Product Classification |
Implantable cardioverter defibrillator (Dual Chamber ) - Product Code LWS
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Product | Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular 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. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias. |
Code Information |
Serial number: PUL450634H. |
Recalling Firm/ Manufacturer |
Medtronic Inc. Cardiac Rhythm Managment 8200 Coral Sea St. N.E. Mounds View MN 55112
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For Additional Information Contact | 763-514-4000 |
Manufacturer Reason for Recall | Medtronic has detected a specific pattern of MOSFET IC malfunctions in its Concerto, Virtuoso and EnRhythm family of devices. The probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant. |
FDA Determined Cause 2 | Process control |
Action | Medtronic, Inc. personnel retrieved 2 non-implanted devices remaining at 2 hospitals. A Performance Notes letter was left at each facility. The Performance Notes described the issue, actions to address issue and recommendations to physicians. The Performance Notes will also be posted on the firm's website. Direct questions about this recall to Medtronic, Inc. by calling 1-763-514-4000. |
Quantity in Commerce | 1 |
Distribution | Nationwide Distribution-- (states of IA and NJ). |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = LWS PMAs with Product Code = LWS
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