BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951930 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23029
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    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

    ACCORDING TO AVAILABLE INFORMATION, THIS RIGHT VENTRICULAR LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE AND RIGHT VENTRICULAR LEAD EXPERIENCED A SHOCK. A REVIEW OF THE ARRHYTHMIA LOGBOOK REVEALED MULTIPLE EPISODES OF NOISE ON ALL CHANNELS. FURTHER INVESTIGATION REVEALED THE NOISE CAUSING OVERSENSING HAD OCCURRED DURING A SURGICAL PROCEDURE WITH ELECTROCAUTERY USE. A MAGNET HAD BEEN APPLIED TO INHIBIT TACHY THERAPY DURING THE PROCEDURE. A REVIEW OF THE INFORMATION COULD NOT DETERMINE WHETHER THERE WAS ASYSTOLE GREATER THAN TWO SECONDS. NO PROGRAMMING CHANGES WERE PERFORMED. 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 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 4474| T165| 0165| 5071| P107| MISMATCH