BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 3210851 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08217
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 29, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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POST MARKET QUALITY ASSURANCE LABORATORY VISUAL OBSERVATION CONFIRMED THAT THE COMPLETE LEAD WAS RETURNED AND THE HELIX WAS RETRACTED. THERE WAS DRIED BLOOD FOUND IN THE HELIX AND UP THROUGH THE LEAD LUMEN. THE CONDUCTOR COILS WERE DEFORMED AND THE INSULATION WAS CUT. THIS DAMAGE WAS DETERMINED TO BE PROCEDURALLY INDUCED.

    Description of Event or Problem · 1

    --

    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
    310084 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4088

    Patients

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