Reason/Issue |
It has been identified that 16 Medtronic Neuromodulation DBS system pocket adaptors (0.08% reported rate of occurrence) have been identified with high impedance, resulting in decreased current being conducted through the device. Some of the reported cases involved loss of therapy, return of symptoms, rebound effects and potential revision surgery to replace the device. There have been no incidents reported in Australia. Analysis of the returned devices found the cause of the high impedance to be conductor wire fractures near where the wire exits the neurostimulator connector block. In two cases, the issue was identified during implantation surgery, while the other 14 were identified after implantation and resulted in revision surgery. |