BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913731 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00434
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 2, 2013
    Report Date
    December 31, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION ILL BE UPDATED

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS FRACTURED FOR A PERIOD OF TIME AND THE DEVICE WAS PROGRAMMED TO AAIR PACING WITH MONITOR+ONLY, THE PATIENT EXPERIENCED SYNCOPE. DUE TO THE PATIENTS CONDITION THE RIGHT VENTRICULAR LEAD WAS NOT REPLACED AND REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20460 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 0041| 0040| 4312| 1871| T167| 0148| 5026| 1600| 1645