BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3211044 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08218
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION NOTED THAT THE COMPLETE LEAD WAS RETURNED WITH SETSCREW MARKS NOTED ON THE TERMINAL PIN, BUT NOT ON THE RING OF THE LEAD. THERE WERE DEFORMED COILS WITH SOME INSULATION PUNCTURE MARKS NOTED, MOST LIKELY DUE TO A GRABBING TOOL USED DURING THE EXPLANT PROCEDURE. THERE WAS DRIED BODILY FLUID FOUND IN THE HELIX HOUSING AND THE HELIX WAS RETRACTED. THE CLINICAL OBSERVATION OF EROSION COULD NOT BE CONFIRMED BY THIS ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ENTIRE SYSTEM WAS EXPLANTED DUE TO EROSION. THE PATIENT WAS SEEN IN THE HOSPITAL FOR AN UNRELATED ISSUE WHEN IT WAS NOTED THAT THE DEVICE HAD ERODED THROUGH THE PATIENT'S SKIN. A TEMPORARY PACING SYSTEM WAS IMPLANTED UNTIL THE RESULTS OF A CULTURE WAS DETERMINED THAT THERE WAS NO INFECTION PRESENT. A NEW SYSTEM WAS LATER SUCCESSFULLY IMPLANTED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311483 FLEXTEND IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R 4088| 4087| K063