An implant card was received that indicated the patient's generator was replaced prophylactically.The lead impedance with the replacement generator was indicated as high, >=10,000 ohms.Diagnostics prior to the generator replacement are unknown to date.The or support specialist company representative indicated that the surgeon does not historically let representatives in the operating room.A surgical resident indicated that there was high impedance, prior to the surgeon entering the room.The representative suggested troubleshooting, but it is unknown to date if the troubleshooting was performed as the representative was not able to go into the room.At the end of the generator replacement case it was reported that there was still high impedance detected, the resident indicated that they inspected the lead and "noticed kinking and a small cut in the lead tubing." no known relevant surgical intervention has occurred with the suspect product, the lead, to date.No further relevant information has been received to date.
|