InjuryNHW
PATCH
Received Jul 22, 2013 · Event occurred Apr 24, 2013
Report 2124215-2013-08459 · MDR key 3240067
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
47 YR
- Unspecified Infection
- Sepsis
Narrative
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.
Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. ADDITIONAL RECEIVED INFORMATION INDICATES THAT THE PATIENT HAD SEPSIS. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS SURGICALLY ABANDONED.