MalfunctionNHW
PATCH
Received Oct 5, 2010 · Event occurred Jul 15, 2010
Report 2124215-2010-17165 · MDR key 1852895
Device
Product problems
- High impedance
- Failure to Convert Rhythm
- Material Integrity Problem
Patient
51 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS EPICARDIAL PATCH EXHIBITED >125 OHMS SHOCK IMPEDANCE IN ALL VECTORS. IT WAS DETERMINED THAT THIS PATCH WHICH WAS PLUGGED INTO THE DISTAL PORT, HAD BECAME FRACTURED. THEREFORE, SHOCK THERAPY COULD NOT BE GUARANTEED. THE PATIENT WAS NOTED AS PACEMAKER DEPENDENT, BUT THERE WAS NO EVIDENCE OF IMPACT ON CRITICAL THERAPY.
Additional Manufacturer Narrative
THIS EPICARDIAL PATCH WAS SURGICALLY ABANDONED. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.