PATCH
Received Jan 19, 2012 · Event occurred Oct 31, 2011
Report 2124215-2012-00757 · MDR key 2421863
Device
Product problems
- High impedance
- Low impedance
Patient
66 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND DEFIBRILLATION LEAD DISPLAYED LOW AND HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PATIENT WAS SEEN IN CLINIC FOR FOLLOW UP WHERE A 1.1 AND 41 JOULE SHOCK WERE DELIVERED TO ASSES THE SYSTEM. BOTH SHOCKS RESULTED IN NORMAL SHOCK IMPEDANCE MEASUREMENTS. IT WAS REPORTED THAT THE PHYSICIAN PLANNED ON EXTRACTING THE SYSTEM FROM THE PATIENT'S ABDOMINAL AREA AND IMPLANTING IN THE PATIENT'S CLAVICULAR AREA. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. AVAILABLE INFORMATION INDICATES THAT THE SYSTEM REMAINS IN SERVICE.
Additional Manufacturer Narrative
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.