PATCH
Received Jul 11, 2011 · Event occurred Apr 12, 2011
Report 2124215-2011-07027 · MDR key 2156296
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
67 YR
- Pocket Erosion
- Surgical procedure, repeated
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT HAD A POCKET EROSION IN HIS ABDOMEN. A REVISION PROCEDURE WAS SCHEDULED. DURING THE REVISION THE PHYSICIAN OPTED TO NOT EXPLANT ALL OF THE PRODUCTS. THE DEVICE, ACTIVE RIGHT VENTRICLAR LEAD AND ADAPTER REMAIN IMPLANTED. TWO PATCHES AND THREE LEADS THAT WERE PREVIOUSLY TAKEN OUT OF SERVICE WERE CLIPPED AND REMAIN IN THE PATIENT'S BODY. THE SUB-Q ARRAY THAT WAS PREVIOUSLY TAKEN OUT OF SERVICE WAS ABLE TO BE EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE ADDITIONAL SURGICAL PROCEDURE.
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.