PATCH
Received Oct 9, 2012 · Event occurred Aug 15, 2012
Report 2124215-2012-11403 · MDR key 2778770
Device
Product problems
- High impedance
Patient
75 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION PATCH LEAD EXHIBITED SHOCK IMPEDANCES GREATER THAN 125 OHMS. DURING THE ROUTINE DEVICE CHANGE OUT, THE LEAD WAS DEACTIVATED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Additional Manufacturer Narrative
THE RIGHT VENTRICULAR (RV) LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC; THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.