ENPATH
Received Apr 6, 2011 · Event occurred Jan 7, 2011
Report 2124215-2011-00843 · MDR key 2041089
Device
Product problems
- Failure to Capture
Patient
71 YR
- Surgical procedure, repeated
Narrative
Additional Manufacturer Narrative
AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATE. AT THIS TIME, OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem
UPDATED INFORMATION: PLEASE NOTE THAT THIS LEAD IS NOT MANUFACTURED BY BOSTON SCIENTIFIC. THEREFORE, THE INITIAL REPORT WAS NOT REQUIRED TO BE SUBMITTED FROM BOSTON SCIENTIFIC.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACER DEPENDENT PATIENT WITH THIS LEFT VENTRICULAR (LV) LEAD WAS HOSPITALIZED AFTER INTERMITTENT LOSS OF CAPTURE (LOC) ON BOTH THE LV AND RIGHT VENTRICULAR (RV) LEAD. THE LV AND RV LEAD ALSO DISPLAYED HIGH PACING THRESHOLDS. A REVISION PROCEDURE WAS PERFORMED DURING WHICH THE LV LEAD WAS TURNED OFF. ATTEMPTS TO PLACE A NEW LV LEAD WERE UNSUCCESSFUL. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.