BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151490 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06142
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED LOW SHOCK IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. THE PATIENT RECEIVED TWO 41 JOULE SHOCKS AND THE SHOCK LEAD INTEGRITY TEST (SLIT) INDICATED SHOCK IMPEDANCE MEASUREMENTS OF 30 AND 29 OHMS FROM THOSE SHOCKS. THERE IS NOISE ON THE SHOCK CHANNEL WHICH COULD BE RELATED TO THE SHOCK VECTOR DISTAL COIL TO CAN. TECHNICAL SERVICES (TS) RECOMMENDED PERFORMING MAXIMUM ENERGY SHOCKS FOR LOW SLIT. 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 73 YR 0185| 4193| 4076| N119| 4591