UNKNOWN
Received Oct 12, 2011 · Event occurred Sep 30, 2011
Report 2124215-2011-17446 · MDR key 2288094
Device
Product problems
- Failure to Capture
- Fracture
- Impedance Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD FLUCTUATION LEFT VENTRICULAR LEAD IMPEDANCES. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN VIA THE LATITUDE HOME MONITORING SYSTEM. UPON A FOLLOW UP, IT WAS DISCOVERED THAT THIS LEFT VENTRICULAR BODY HAD SEPARATED FROM PORTION OF THE LEAD WHICH WAS CONNECTED INTO THE DEVICE, THUS A LEAD FRACTURED WAS CONFIRMED. IN ADDITION, LOSS OF CAPTURE WAS CONFIRMED. A REVISION PROCEDURE TOOK PLACE. THE WHOLE LEAD COULD NOT BE RETRIEVED FROM THE BODY THUS A PORTION OF THIS LEAD WAS LEFT INSIDE THE PATIENT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED. A NEW COMPETITOR LEAD WAS IMPLANTED.
Additional Manufacturer Narrative
THIS REPORT HAS ALREADY BEEN SUBMITTED. (B)(4).
Additional Manufacturer Narrative
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem
.