BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIGEN RADIOFREQUENCY GENERATOR

    MDR report key: 3020009 · Received March 25, 2013

    Report

    Report Number
    0001811755-2013-00598
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED. BASED ON THE INFORMATION GIVEN IN THE REPORTED EVENT AND THE ADDITIONAL INFORMATION RECEIVED DURING FOLLOW UP WITH THE SALES REP, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE DUE TO UNINTENDED STIMULATION DURING THE SENSORY MODE. THIS IS KNOWN TO BE AN INHERENT EFFECT OF THE MULTIGEN.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE. (B)(4): DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNINTENDED SENSORY STIMULATION DURING A PROCEDURE AND THE CASE NEEDED TO BE CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNINTENDED SENSORY STIMULATION DURING A PROCEDURE AND THE CASE NEEDED TO BE CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122530 MULTIGEN RADIOFREQUENCY GENERATOR GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1