MalfunctionNHW
PATCH
Received Oct 10, 2011 · Event occurred Sep 6, 2011
Report 2124215-2011-15492 · MDR key 2283828
Device
Product problems
- High impedance
Patient
77 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS EPICARDIAL LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
OUR RECORDS INDICATE THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.