Potential Reduced Device Longevity
Concerto CRT-D and Virtuoso ICD
Original Date of Advisory:
A subset of Concerto CRT-D and Virtuoso ICD devices may not meet expected device longevity. You may use the "Search for Information by Serial Number" tool on this web page to determine if a specific device is affected.
A subset of Concerto CRT-D and Virtuoso ICD devices 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 functionality or affect therapy delivery.
Based on information from returned devices, Medtronic expects that affected devices will continue to provide at least 3 months of normal device function between RRT and End of Service (EOS) as described in device labeling.
A total of 8,900 devices worldwide are affected by this advisory. An estimated 6,300 of these devices were active at the time of the original advisory communication.
Concerto and Virtuoso devices in the affected subset were manufactured primarily in 2006 and can be traced to a specific subset of low voltage capacitors.
Patient Management Recommendations
After consultation with Medtronic’s Independent Physician Quality Panel, Medtronic offers the following recommendations for patients with devices in the affected subset:
Physicians should continue routine follow-up sessions at least every 3 months in accordance with product labeling.
Physicians should verify that the Low Battery Voltage RRT alert is programmed to “On-High.” This provides an audible, alternating tone when the device reaches RRT. These devices are shipped with this alert programmed nominally to “On-High.”
Physicians may consider monitoring patients through CareLink. The CareLink home monitor can be used to automatically notify the clinician when the device reaches RRT.
As of September 10, 2013, 3,684 devices out of approximately 8,900 devices in this subset worldwide have been confirmed as having exhibited this capacitor degradation. Out of the initial advisory population of 8,900 worldwide, less than 300 remain implanted worldwide.
|Initial Affected Population||Number of Confirmed Advisory Related Events||Estimated Remaining Active Population||Current Malfunction Rate (confirmed malfunctions over total population)|
8,900 implanted worldwide (7,000 United States)
3,684 Worldwide (3,168 United States)
<300 Worldwide (<300 United States)
41% Worldwide (45% United States)