BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2051663 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-05204
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE FOR RESOLUTION HOWEVER, NOTHING FURTHER WAS RECEIVED FROM THE FIELD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED NOISE AND AN UNKNOWN LENGTH OF PACING INHIBITION ON THIS DEFIBRILLATION LEAD. THERE WAS INQUIRY OF TELEMETRY DROP OUT AND/OR RADIO FREQUENCY ISSUES. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING. NO ADVERSE PATIENT EFFECTS WERE 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 80 YR MISMATCH| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)