BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 2902525 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00431
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    October 31, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING AN INAPPROPRIATE SHOCK. UPON INTERROGATION, AT LEAST ONE UNSUCCESSFUL SHOCK AND POSSIBLE OUTPUT CIRCUIT DAMAGE WERE OBSERVED. REVIEW OF SUBSEQUENT CHARGING STRIPS INDICATED THAT THE DEVICE WAS NOT CHARGING. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10125 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR (B)(4)