BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 4030713 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14651
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    May 2, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP THE DEVICE EXHIBITED OVERSENSING ON BOTH THE ATRIAL AND VENTRICULAR CHANNELS. THE DEVICE WAS REPROGRAMMED TO ADDRESS THE ATRIAL OVERSENSING ONLY, AS THE VENTRICULAR OVERSENSING COULD NOT BE REPRODUCED IN CLINIC. AT A LATER FOLLOW-UP THE DEVICE CONTINUED TO EXHIBIT VENTRICULAR OVERSENSING AND ALSO SHOWED OCCASIONAL UNDERSENSING ON THE ATRIAL CHANNEL. THE DEVICE WAS REPROGRAMMED TO ADDRESS THE VENTRICULAR OVERSENSING AND REMAINS IMPLANTED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510197 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 55 YR