BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910764 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00612
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    October 3, 2012
    Report Date
    November 19, 2012
    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

    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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. ALL SUBSEQUENT SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED TO BE STABLE AND ACCEPTABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18123 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 0184| 4517| 1888TC| MISMATCH| N118