InjuryNHW
POSSIS
Received Jul 1, 2015 · Event occurred Apr 24, 2015
Report 2124215-2015-06455 · MDR key 4883139
Device
Product problems
- Over-Sensing
- Inappropriate/Inadequate Shock/Stimulation
- Device Sensing Problem
Patient
70 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT RECEIVED 28 INAPPROPRIATE SHOCKS DUE TO NOISE AND OVERSENSING OF THE RIGHT VENTRICULAR (RV) LEAD AND RESULTED IN DEVICE THERAPY EXHAUSTION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND ADVISED THAT THE INTEGRITY OF THE LEAD SYSTEM IS IN QUESTION. THE LEADS WERE CAPPED AND REPLACED. NO 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.