BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 2984323 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00579
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 15, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. ANALYSIS FOUND HIGH VOLTAGE OUTPUT CIRCUIT DAMAGE ON THE DEVICE, CONSISTENT WITH LEAD DAMAGE. THE LOW VOLTAGE FUNCTIONALITY WAS TESTED ON THE BENCH AND ON OUR AUTOMATED TESTING EQUIPMENT. ALL OF THE LOW VOLTAGE TEST SPECIFICATIONS WERE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR ROUTINE DEVICE CHANGE OUT. DURING DFT TESTING, THE DEVICE FAILED TO TERMINATE VF. THE PATIENT WAS RESCUED USING EXTERNAL DEFIBRILLATOR. THE DEVICE WAS LATER FOUND IN BVVI MODE WITH NO COMMUNICATION CAPABILITY. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87632 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3261-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1