BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 3210622 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03426
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 19, 2013
    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
    IL
    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 IN HOSPITAL AFTER EXPERIENCING MULTIPLE SHOCKS, EXTENDED CHARGE TIME ALERT WAS OBSERVED. MANUAL CAP MAINTENANCE WAS PERFORMED WITH NORMAL VALUE. THE DEVICE WILL BE MONITORED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310338 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR