The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality,” according to a January doctors letter from quality & regulatory VP Tim Samsel.
The issue led to a single instance in which an implanted device failed, in which external defibrillation was required to rescue the patient. The affected CRT-Ds are from Fridley, Minn.-based Medtronic’s Amplia, Claria, Compia and Viva lines. The ICDs involved in the recall are from the Evera and Visia lines.
“Due to the nature of this issue, it is not possible to identify which of these 48 devices may fail or when they may fail. Further, we cannot predict how many high-voltage charges can occur prior to a potential failure,” Samsel wrote.
Tests on a small number of devices made using the same technique showed that the failure occurred in 23% of devices; 7.7% of the tested devices failed within the first two high-voltage charges, the company said in the letter. The FDA yesterday gave the recall Class I status, denoting the risk of serious injury or death.
Patients implanted with the affected devices might need to have them replaced, according to the letter.
“Prophylactic device replacement should be strongly considered for patients who have been implanted with one of the devices listed in Appendix A. Medtronic will offer a supplemental device warranty for this affected population,” the company said. “We sincerely regret any difficulties this may cause you and your patients.”
A list of the serial numbers of the affected devices can be found here.