BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1140631 · Received August 28, 2008

    Report

    Report Number
    9614453-2008-05286
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ANY THERAPEUTIC BENEFIT FROM THE DEVICE. WHEN THE DEVICE WAS TURNED ON, THE PATIENT REPORTED PAIN AND HEAT AT THE NEUROSTIMULATOR SITE. THE DEVICE WAS PROGRAMMED AT +VE, ELECTRODE 0 WAS - VE, PULSE WIDTH 210 MICROSECONDS AND RATE 31 HZ. WHEN THE ELECTRODE CONFIGURATIONS WERE CHANGED, THE PATIENT NO LONGER REPORTED PAIN AND HEAT AT THE NEUROSTIMULATOR SITE. THE PATIENT DID NOT RECEIVE THERAPEUTIC BENEFIT IN THE DESIRED LOCATION, THE LEGS, AFTER THE ELECTRODE CONFIGURATIONS WERE CHANGED. PREVIOUS TO THIS, THE DEVICE WAS WORKING WELL. THE DEVICE FAILURE WAS NOT ASSOCIATED WITH ANY TRIP OR FALL. NO PATIENT INJURY WAS REPORTED. AS OF 2008, THE DEVICE HAD BEEN TURNED OFF. THE DEVICE HAS NOT BEEN REPLACED. THE PATIENT WAS FINE. THE PATIENT WAS AWAITING FOR A SURGERY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC SWISS MANUFACTURING FACILITY 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention