BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAIN MANAGEMENT GENERATOR

    MDR report key: 3007381 · Received March 15, 2013

    Report

    Report Number
    1033422-2013-00013
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    February 14, 2013
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    GXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD IS PENDING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS, THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS REPORTED EVENT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS. DEVICE NOT RETURNED TO KIMBERLY-CLARK BY CUSTOMER.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, "WHEN THE PMG WAS TURNED ON THE TEMPERATURE WENT UP WAY TOO HIGH AND THE PATIENT WAS IN EXTREME PAIN, THE PMG WAS SHUTOFF MANUALLY. THE TEMPERATURE IN THE ADJUSTABLE SETTINGS WAS SET AT 85 DEGREES. THE RAMP UP WAS NORMAL BUT THE TEMPERATURE CONTINUED TO GO UP BEYOND 95 DEGREES AND THE PMG DID NOT SHUT OFF. THE HEAT WAS SO UNBEARABLE FOR THE PATIENT THAT THE PMG HAD TO BE TURNED OFF MANUALLY. THE PHYSICIAN READJUSTED THE NEEDLE THREE TIMES AND ATTEMPTED THE PROCEDURE ONCE MORE, EACH TIME THE SAME PROBLEM OCCURRED. EACH TIME THE TEMPERATURE WAS OVERSHOOTING BY 10 DEGREES. ON THE FOURTH NEEDLE READJUSTMENT, THE PMG WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT OVERSHOOTING THE TEMPERATURE. THE PHYSICIAN NOTED THAT THERE WAS QUITE A BIT OF SCAR TISSUE (PATIENT HAD PREVIOUS SURGERY) BUT HE DID NOT NOTICE AN IMPEDANCE READING". KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS RECORD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108840 PAIN MANAGEMENT GENERATOR RADIO FREQUENCY GENERATOR GXI KIMBERLY-CLARK HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR