BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3854620 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11517
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 11, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    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 DURING DEVICE INTERROGATION, WIDE QRS OVERSENSING WAS OBSERVED. THE PATIENT WAS FOUND TO HAVE LOW POTASSIUM LEVELS. PROGRAMMING CHANGES WERE NOT MADE. PATIENTS CONDITION WAS ATTEMPTED TO BE STABILIZED. AT THE NEXT DEVICE CHECK, THE DEVICE WAS FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332372 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR