BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EP-4 STINULATOR, 4 CAHNNEL

    MDR report key: 2590472 · Received May 24, 2012

    Report

    Report Number
    2184149-2012-00014
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 2, 2012
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    JOQ
    PMA / PMN Number
    K092913
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION IS COMPLETED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN ABLATION PROCEDURE, THE STIMULATOR WAS SENDING IMPROPER STIMULUS TO THE PT. THE PHYSICIAN WAS USING THE F5 PROTOCOL AND WANTED TO PACE AT 600 MS, BUT THE STIMULUS THAT WAS SENT WAS 465 MS. THE PHYSICIAN CHECKED THE SETTINGS AND STIMULATED AND THEN SAW THE VALUES WERE NOT WHAT HAD BEEN PROGRAMMED. THE PROCEDURE WAS STOPPED WITH NO CONSEQUENCES TO THE PT. ADDITIONAL INFO WAS REQUESTED AND IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EP-4 STINULATOR, 4 CAHNNEL EP RECORDING SYSTEM JOQ ST. JUDE MEDICAL, AF DIVISION 09-1527-0000

    Patients

    Seq Age Sex Outcome Treatment
    1