BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIGEN RADIOFREQUENCY GENERATOR

    MDR report key: 3143214 · Received June 3, 2013

    Report

    Report Number
    0001811755-2013-01286
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE NOT BEING RETURNED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT'S ON-DEMAND PACEMAKER HAD AN ADDITIONAL DISCHARGE. THE FACILITY DISCONTINUED THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES AND THERE WAS NO MEDICAL INTERVENTION. ACCORDING THE THE DEVICE INSTRUCTIONS FOR USE, "DO NOT USE THIS EQUIPMENT WITH PATIENTS HAVING A CARDIAC PACEMAKER OR PACEMAKER ELECTRODES UNLESS OTHERWISE DIRECTED BY THE (B)(6)."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE PATIENT'S ON-DEMAND PACEMAKER HAD AN ADDITIONAL DISCHARGE. THE FACILITY DISCONTINUED THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES AND THERE WAS NO MEDICAL INTERVENTION. ACCORDING THE DEVICE INSTRUCTIONS FOR USE, "DO NOT USE THIS EQUIPMENT WITH PATIENTS HAVING A CARDIAC PACEMAKER OR PACEMAKER ELECTRODES UNLESS OTHERWISE DIRECTED BY THE COGNIZANT CARDIOLOGY DEPARTMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244004 MULTIGEN RADIOFREQUENCY GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1