BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911494 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16799
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE. 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 PATIENT PRESENTED TO THE EMERGENCY ROOM FOR AN UNRELATED REASON. THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. ALL SUBSEQUENT MEASUREMENTS WERE STABLE AND ACCEPTABLE. IT WAS REPORTED THAT SHOCK IMPEDANCE MEASUREMENTS HAD INCREASED SLIGHTLY POST IMPLANT, HOWEVER, WERE NOT OUT OF RANGE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POTENTIAL ELECTROMAGNETIC INTERFERENCE (EMI) AS THE PATIENT WAS CONNECTED TO TELEMETRY AND THERE WERE SURFACE ELECTRODES CLOSE TO THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17657 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 0296| 4136| E142