InjuryNHW
ENPATH
Received Jan 6, 2011 · Event occurred Nov 23, 2010
Report 2124215-2011-00047 · MDR key 1951635
Device
Product problems
- Extrusion
Patient
69 YR
- Unspecified Infection
- Pocket Erosion
Narrative
Additional Manufacturer Narrative
IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WILL BE EXPLANTED DUE TO AND INFECTION AND POCKET EROSION. IT WAS NOTED THAT THE HEADER OF THE DEVICE IS EXPOSED AND THE PATIENT IS PACEMAKER DEPENDENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED AND THIS LEAD WAS EXPLANTED.