BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 3914580 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13175
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE OVERSENSED ONE EVENT THAT INHIBITED BI-V PACING. MYOPOTENTIAL OVERSENSING WAS SUSPECTED. PROGRAMMING CHANGES WERE RECOMMENDED. THE PHYSICIAN SUSPECTED THE PATIENTS LOW MAGNESIUM LEVELS WERE A CONTRIBUTING FACTOR. NO CHANGES WERE MADE AND PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389815 UNIFY CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3235-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR