MalfunctionNHW
PATCH
Received Jul 14, 2011 · Event occurred Apr 19, 2011
Report 2124215-2011-06971 · MDR key 2162498
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
61 YR
- Unspecified Infection
Narrative
Additional Manufacturer Narrative
ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 PATIENT IMPLANTED WITH THIS PRODUCT SUFFERED FROM A DEVICE POCKET INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS.