BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 3911045 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-13031
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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 EMERGENCY ROOM. POST-SENSED T-WAVE OVERSENSING WAS OBSERVED ON STORED EGM, AND THE DEVICE DELIVERED INAPPROPRIATE THERAPY. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385923 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention