PATCH
Received Apr 9, 2012 · Event occurred Feb 23, 2012
Report 2124215-2012-03041 · MDR key 2522321
Device
Product problems
- High impedance
- Device Operates Differently Than Expected
Patient
43 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THESE TWO EPICARDIAL PATCHES WERE EXHIBITING HIGH SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 200 OHMS. IT WAS UNKNOWN WHICH PATCH WAS RESPONSIBLE. HOWEVER, IT WAS REPORTED THAT THE REAR PATCH WAS BEGINNING TO SEPARATE FROM THE HEART. A REVISION PROCEDURE WAS PERFORMED AND BOTH PATCHES WERE SURGICALLY ABANDONED. A NEW SYSTEM WAS IMPLANTED SUB MAMMARY. NO INVESTIGATION PLANNED TO BE PERFORMED TO DETERMINE WHICH EPICARDIAL PATCH WAS RESPONSIBLE FOR THE HIGH IMPEDANCE MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
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.