PATCH
Received Jan 11, 2013 · Event occurred Nov 30, 2012
Report 2124215-2013-00017 · MDR key 2911899
Device
Product problems
- High impedance
- Low impedance
- Material Integrity Problem
Patient
53 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE-OUT PROCEDURE TO A COMPETITOR'S DEVICE, THESE EPICARDIAL PATCHES WERE EVALUATED WITH A PACING SYSTEM ANALYZER (PSA). THE IMPEDANCE RESULTS WERE > 2000 OHM ON ONE PATCH AND THE OTHER MEASURED < 200 OHMS. THE FIELD REPRESENTATIVE DID NOT KNOW WHICH PATCH HAD WHICH RESULT AS HE WAS NOT DIRECTLY INVOLVED IN THE CASE. A SHOCK WAS THEN DELIVERED THROUGH THE NEW DEVICE, DONE IN THE PATCH TO PATCH OR COLD CAN CONFIGURATION, AND THE MEASURED IMPEDANCE VALUE WAS >200 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH THE FIELD REPRESENTATIVE THAT HAVING A READING OF > 2000 OHMS, AND THEN A SHOCK LEAD IMPEDANCE OF > 200 OHMS, WERE OUT OF RANGE, AND POTENTIAL CAUSES WERE DISCUSSED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATCHES WERE SURGICALLY ABANDONED AND A NEW TRANSVENOUS LEAD WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS.
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.