BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041415 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01074
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THIS DEVICE REMAINS IMPLANTED NO ANALYSIS WILL BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A REVISION PROCEDURE TO REPLACE THE LEFT VENTRICULAR LEAD DISCHARGE WAS NOTED AROUND THE POCKET OF THIS CARDIAC RESYNCHONIZATION THERAPY DEFIBRILLATOR (CRT-D). A CULTURE SAMPLE WAS TAKEN AND AN INFECTION WAS SUSPECTED. AT THIS TIME, THE DEVICE AND RIGHT ATRIAL AND RIGHT VENTRICULAR REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 0185| 4542| 4554| M170| 4480