BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR

    MDR report key: 3872917 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11779
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    April 23, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION SHOWED EPISODES OF NON SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING ON THE VENTRICULAR CHANNEL. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350017 UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR