UNKNOWN
Received Apr 6, 2011 · Event occurred Jan 13, 2011
Report 2124215-2011-01565 · MDR key 2041847
Device
Product problems
- Failure to Capture
- High impedance
- Under-Sensing
Patient
58 YR
- No Consequences Or Impact To Patient
Narrative
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.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING LEAD IMPEDANCE, INCREASED PACING THRESHOLDS WITH NO CAPTURE AND UNDERSENSING IS SUSPECTED. DURING EVALUATION THE PATIENT REPORTED HE HAS NOT BEEN TO FOLLOW SINCE IMPLANT EIGHT YEARS AGO. THE RV LEAD REMAINS IN SERVICE. THE PATIENT IS UNDER THE CARE OF A PHYSICIAN AND THE LEAD MAY BE REVISED IN THE FUTURE. NO ADVERSE PATIENT EFFECTS REPORTED.