BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4150876 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17978
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    May 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING WITH PACING INHIBITION GREATER THAN 2 SECONDS OF ASYSTOLE. IT WAS NOTED THAT LEFT VENTRICULAR (LV) LEAD THRESHOLD TEST WAS PERFORMED IN VVI. THE DEVICE WENT BACK TO DDD AND MODE SWITCHED AFTER AND STORED THE EVENT. THE PATIENT HAD ATRIAL FIBRILLATION (AF) WHEN THE ATRIAL TACHY RESPONSE (ATR) EVENT WAS STORED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THIS DEVICE AND LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633591 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR N119| H177| 4554| 1488T| 0185