BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 1945650 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20121
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Removal / Correction Number
    Z-1144/1145-9
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS PRODUCT REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THIS IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE OUT OF RANGE MEASUREMENTS WERE OBSERVED IN THE TRIAD CONFIGURATION. IMPEDANCE MEASUREMENTS WERE THEN TAKEN IN THE COIL TO CAN CONFIGURATION AND ACCEPTABLE MEASUREMENTS WERE OBSERVED. THE DEVICE WAS REPROGRAMMED TO THE COIL TO CAN CONFIGURATION AND THE OUTPUT WAS REPROGRAMMED TO MAXIMUM ENERGY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 1860| 0125| 1782| E102