POSSIS
Received Jul 29, 2011 · Event occurred Jun 27, 2011
Report 2124215-2011-12788 · MDR key 2183560
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
73 YR
- Unspecified Infection
Narrative
Description of Event or Problem
AN EVENT INVOLVING THIS NON-BOSTON SCIENTIFIC PRODUCT WAS REPORTED IN ERROR. BOSTON SCIENTIFIC DOES NOT HAVE REPORTING OBLIGATIONS FOR THIS PRODUCT, THEREFORE REFUTING THE ORIGINAL REPORT.
Additional Manufacturer Narrative
THE LEAD REMAINS SURGICALLY ABANDONED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Additional Manufacturer Narrative
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Description of Event or Problem
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT SURGICAL AND MEDICAL INTERVENTION WAS PERFORMED TO REMOVE AN INFECTION IN A PATIENT WITH THIS PREVIOUSLY SURGICALLY ABANDONED LEAD. SURGICAL INTERVENTION WAS PERFORMED TO CLEAN THE INFECTION, HOWEVER THE PATIENT SYSTEM WAS NOT REVISED. THE PATIENT WAS ALSO GIVEN INTRAVENOUS MEDICATION TO HELP HEAL THE INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.