BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1945584 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19941
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 11, 2010
    Report Date
    October 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT WAS BROUGHT INTO THE CLINIC AND SHOCKING IMPEDANCE MEASUREMENTS HAD RETURNED TO NORMAL RANGE. ATTEMPTS TO PRODUCE NOISE WERE MADE AND COULD NOT BE CREATED. THERE ARE NO PLANS FOR ADDITIONAL INTERVENTION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A LATITUDE RED ALERT THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD DISPLAYED A LOW SHOCKING IMPEDANCE MEASUREMENT LESS THAN 20 OHMS. IT APPEARED TO BE A ONE TIME OCCURRENCE. ALL OTHER LEAD DIAGNOSTICS WERE WITHIN NORMAL RANGE. THERE WAS NO NOISE ON THE PRESENTING ELECTROGRAM (EGM) OR ANY OF THE STORED EGMS IN THE ARRHYTHMIA LOGBOOK. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    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 59 YR 4525| H175| N118| 4470| 0185