In a June letter to physicians, Fridley, Minn.-based Medtronic said it learned of 16 instances of high impedance measurements that were later found to be caused by wire fractures. The fractures, in adaptor wires connected to pocket adaptors for the Activa PC and Activa RC devices.
Although the fractures occurred in just 0.08% of the roughly 20,000 Activa devices implanted since 2009, the company reinforced its instructions on using the devices as 14 of the 16 required explantation (2 fractures were discovered during the implantation procedure, Medtronic said).
The risk of wire fractures is similar to an issue Medtronic warned about in April 2015 with its DBS Extensions devices, the company said.
“To minimize the potential for a conductor wire fracture, please follow the instructions defined within the DBS Pocket Adaptor Implant Manual as shown below, to ensure that the adaptor wire is not bent sharply or kinked at the time of implant. The full implant manual can be found in product packaging,” Medtronic said.