Related manufacturer reference number: 1627487-2022-01851, 1627487-2022-01852, 1627487-2022-01853, 1627487-2022-01854, 1627487-2022-01855, 1627487-2022-01856, 1627487-2022-01857, 1627487-2022-01858.It was reported during an ipg revision (reference 1627487-2022-01845), the physician planned to add an extension to the existing lead so it could be routed to the new ipg pocket.The physician had trouble securing the existing lead to the new extension.As a result, the physician decided not to use the extension, unbury the existing lead and tunnel it to the new ipg site.The surgery was extended 2 hours.
|
The report event of stuck set screw was confirmed.As received, the returned lead extension set screw was found stuck against the retaining washer in the connector assembly due to over-torque condition.The cause of the event is consistent with damage during use.There is adequate information in the clinician's manual that addresses proper loosening and tightening of the set screw.The report event of high impedance was not confirmed.As received, the returned lead extension worked properly and passed test.The cause of the reported event remains unknown.
|