BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 4021869 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14418
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    June 19, 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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC FOR FOLLOW UP WHEN INTERROGATING THE DEVICE WAS DIFFICULT. THE TELEMETRY WAS OBSERVED TO BE LOST WHEN IT WAS SWITCHED TO THE RF ANTENNA. THE ANTENNA WAS UNPLUGGED AND DEVICE INTERROGATION WAS COMPLETED. PATIENT AND DEVICE MONITORING WILL CONTINUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499985 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 68 YR