Medtronic Advisory Says Some Concerto, Virtuoso Defibrillator Batteries May Deplete PrematurelySep 11, 2009 | Parker Waichman LLP
Medtronic Inc. has issued an advisory for 6,300 Concerto CRT-D and Virtuoso implantable defibrillators. According to the advisory, the batteries on these devices may be depleted sooner than normal
According to a letter sent to physicians, the devices affected by this advisory will give a 90-day advanced warning if the batteries are nearing depletion. Medtronic maintains that the battery issue does not compromise device functionality or affect therapy delivery. The company said it has received no reports of death or injury attributed to this issue.
The 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, Medtronic said. So far, there have been no related confirmed failures in Concerto and Virtuoso devices outside of this subset, including devices that were manufactured during the same time, the letter said.
Medtronic is offering the following recommendations for patients with Virtuoso and Concerto CRT-D devices in the affected subset:
- Physicians should continue routine follow-up sessions at least every three months in accordance with product labeling.
- Physicians should verify that the Low Battery Voltage Recommended Replacement Time (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.
Patients can determine if their device is included in this advisory by visiting http://CVSNList.medtronic.com. Patients will need the serial number of their device, which is available on their Medtronic patient identification card.