PATCH
Received Apr 15, 2011 · Event occurred Mar 25, 2011
Report 2124215-2011-05681 · MDR key 2059429
Device
Product problems
- Fracture
- High impedance
- Device Sensing Problem
Patient
61 YR
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
NEW INFORMATION WAS RECEIVED THAT THIS PATIENT IS ALSO EXHIBITING NOISE AS WELL AS CONTINUED HIGH OUT OF RANGE SHOCKING IMPEDANCES. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT UNDERWENT A ROUTINE ABDOMINAL DEVICE CHANGE OUT WHEN THE SHOCKING IMPEDANCE ROSE TO GREATER THAN 125 OHMS. THE LEAD WAS TESTED IN A COIL TO COIL CONFIGURATION WHERE IT WAS OVER 125 OHMS, THEN IT WAS TESTED COIL TO DEVICE WHERE THE IMPEDANCE WAS NORMAL. AS A RESULT IT IS BELIEVED THAT IT COULD BE A PROXIMAL PATCH THAT IS THE PROBLEM. IT WAS VERIFIED THAT THE SETSCREWS WERE IN THE CORRECT POSITION AND A TUG TEST WAS DONE AT IMPLANT TO VERIFY LEAD CONNECTION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND STATED THAT WE CANNOT RULE OUT A LOOSE SETSCREW ISSUE OR A SMALL PATCH CONDUCTOR FRACTURE. FURTHER TESTING SHOULD BE PERFORMED TO CONFIRM THERAPY EFFECTIVENESS.
Additional Manufacturer Narrative
AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AS NECESSARY.
Additional Manufacturer Narrative
BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THAT SINCE THIS IS AN ABDOMINAL IMPLANT, THE VECTOR GOES DIRECTLY OVER THE DIAPHRAGM SO IT IS POSSIBLE THAT IS MIGHT BE MYOPOTENTIAL. TS ALSO SUGGESTED TO TRY SOME MANIPULATION IN AND AROUND THE DIAPHRAGM TO DIAGNOSE POSSIBLE CONNECTION ISSUES. THE SYSTEM REMAINS IMPLANTED AT THIS TIME.