BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSSIS

    MDR report key: 2183584 · Received July 29, 2011

    Report

    Report Number
    2124215-2011-12789
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 27, 2011
    Report Date
    September 28, 2011
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    NHW
    PMA / PMN Number
    P830060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    --

    Description of Event or Problem · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSSIS IMPLANTABLE LEAD NHW EXTERNAL MANUFACTURER 4320

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R E102| 0040| 4320| 0155| 1705| 1746| 1860