MalfunctionNHW
PATCH
Received Apr 6, 2012 · Event occurred Jan 27, 2012
Report 2124215-2012-01718 · MDR key 2520267
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Product code (NHW)
Model (0041)
Device
Product problems
- Fracture
Patient
50 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A NORMAL DEVICE CHANGEOUT, THIS EPICARDIAL LEAD PATCH WAS NOTED TO BE FRACTURED. FLUOROSCOPY CONFIRMED THAT THERE WAS A BREAK IN THE PATCH CONDUCTOR COILS. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
THE LEAD WAS SURGICALLY ABANDONED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.