It was reported that during a revision procedure when they took the left ventricular (lv) lead out there was blood in the insulation.A new lead was used, and they wiped it off and there is still blood within the insulation.Additionally, there were observations of loss of capture and sensing.Technical services recommended to use a different lead and to return it for device analysis.Attempts were made to the field representative for additional information however, no new information was obtained.No additional adverse patient effects were reported.
|