BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3910006 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-10903
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 11, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WILL CONTINUE TO BE MONITORED. 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 IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. IT WAS REPORTED THE MEASUREMENT OCCURRED ONE DAY POST IMPLANT WHILE THE PATIENT WAS STILL IN THE HOSPITAL. ELECTROMAGNETIC INTERFERENCE (EMI) WAS DISCUSSED AS A POSSIBLE CAUSE. ALL OTHER MEASUREMENTS WERE ACCEPTABLE AND SUBSEQUENT SHOOK IMPEDANCE MEASUREMENTS WERE WITHIN RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387697 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR 4469| 0295| N160| 4592