BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213063 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09973
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    April 17, 2013
    Report Date
    June 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED INCREASED THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE (LOC) FIVE DAYS POST IMPLANT. SUBSEQUENTLY, THE PATIENT PRESENTED FOR A LEAD REVISION PROCEDURE APPROXIMATELY TWO MONTHS LATER. THE LEAD WAS OBSERVED TO HAVE DISLODGED. A REVISION PROCEDURE WAS PERFORMED. THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312758 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 4470| E162| 0293