BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1500T12 GENERATOR

    MDR report key: 2043260 · Received February 25, 2011

    Report

    Report Number
    2030404-2011-00055
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE START/STOP KEY WAS PRESSED TO INITIATE RF ENERGY DELIVERY BUT THE BUTTON ITSELF DID NOT COME BACK TO ITS NORMAL POSITION. RF ENERGY WAS APPLIED NORMALLY BUT WHEN THE PHYSICIAN ATTEMPTED TO STOP RF DELIVERY, PUSHING THE START/STOP KEY DID NOT STOP DELIVERY. THE START/STOP KEY WAS PRESSED REPEATEDLY WHICH ALLOWED THE BUTTON TO COME BACK TO ITS NORMAL POSITION AND THEN DELIVERY WAS ABLE TO BE STOPPED. THERE WERE NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1500T12 GENERATOR CARDIAC ABLATION GENERATOR OAD ST. JUDE MEDICAL, IRVINE 100025753 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR