PATCH
Received Jan 10, 2013 · Event occurred Oct 9, 2012
Report 2124215-2012-14343 · MDR key 2906783
Device
Product problems
- High impedance
Patient
79 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A COMPETITIVE FIELD REPRESENTATIVE THAT AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF 168 OHMS WAS OBSERVED ON THEIR DEVICE. DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) THAT THE PHYSICIAN MAY WANT TO CONSIDER ADDITIONAL TESTING TO DETERMINE THE INTEGRITY OF THE LEAD. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LOCAL FIELD REPRESENTATIVE WAS CONTACTED, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
TO THIS DATE THIS LEAD REMIANS IMPLANTED WITH NO CHANGE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.