PATCH
Received Jan 5, 2011 · Event occurred Oct 28, 2010
Report 2124215-2010-21049 · MDR key 1947800
Device
Product problems
- Fracture
- Impedance Problem
Patient
71 YR
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE LEADS WERE CAPPED AND ABANDONED AND SUCCESSFULLY REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE AND THE LEADS WILL NOT BE RETURNED FOR ANALYSIS. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Additional Manufacturer Narrative
A SYSTEM REPLACEMENT HAS BEEN SCHEDULED FOR A LATER DATE. IT IS UNKNOWN IF THIS LEAD WILL BE RETURNED ONCE IT IS EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.
Description of Event or Problem
A REVISION WAS PERFORMED AND REVEALED THAT BOTH PATCH LEADS WERE FRACTURED.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE OF THESE TWO EPICARDIAL PATCH LEADS HAS AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. AT THIS TIME, IT IS UNKNOWN WHICH LEAD IS CAUSING THE OUT OF RANGE MEASUREMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.