Medtronic has reported an issue with the long-term battery performance of its InSync III cardiac resynchronisation therapy-pacemakers (CRT-P) (models 8042, 8042B and 8042U). The Food and Drug Administration (FDA) has designated this issue as a Class II recall.
In a letter addressed to physicians, Medtronic noted that the cause of the problem is “unexpected high battery impedance” and that, as of 27 October 2015, 30 devices, which were implanted 53 months ago or more, have been affected worldwide. In total, the company manufactured 96,800 devices and 22,000 remain active. Medtronic estimates a failure rate between 0.16% and 0.6% for the remaining active devices; however, it states that “due to the unpredictable nature of this issue, it is not possible to identify which devices might fail or when they might fail. The issue cannot be mitigated by programming changes or increasing patient follow-up frequency.”
Medtronic reported that unexpected loss of pacing capture was detected in 12 of the 30 devices and the other 18 experienced some form of erratic behaviour, including early elective replacement indication, significant fluctuations in remaining longevity estimates, and inaccurate lead impedances. The company also received a report of a patient death, commenting “where it is possible, but unconfirmed” that the battery issue was a contributing factor.
“If pacing capture is compromised, some patients may experience a return of heart failure symptoms due to loss of biventricular pacing. In cases involving pacemaker-dependent patients, a loss of pacing capture could result in serious injury or death,” Medtronic wrote in the aforementioned letter to physicians.
The designation as a Class II recall, as stated by the FDA, means that the product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
After consultation with Medtronic’s Independent Physician Quality Panel (IPQP), Medtronic has recommended physicians:
- Do not perform prophylactic device replacement in non-pacemaker-dependent patients.
- For pacemaker-dependent patients, physicians should carefully weigh the risks and benefits of device replacement to mitigate this issue on an individual patient basis.
- Continue routine patient follow up in accordance with standard practice, and advise patients to seek medical attention immediately if they experience new or unexpected symptoms.
Medtronic noted that InSync III CRT-P devices are an older set of devices that are no longer being distributed and that it will continue to monitor device performance and provide regular updates on wwwp.medtronic.com/productperformance/