InjuryNHW
ENPATH
Received Jan 10, 2012 · Event occurred Nov 3, 2011
Report 2124215-2011-19468 · MDR key 2406250
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
69 YR
- Unspecified Infection
Narrative
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.
Additional Manufacturer Narrative
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, (B)(4) INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.