BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3090282 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01242
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 DURING IMPLANT, POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD WAS OBSERVED ON A REAL-TIME EGM. REPROGRAMMING OPTIONS WERE RECOMMENDED. THE PHYSICIAN DECIDED TO MAKE HIS OWN PROGRAMMING CHANGES. NO OVERSENSING WAS REPORTED AFTER THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191513 UNIFY ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR