BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3201922 · Received July 2, 2013

    Report

    Report Number
    6000032-2013-00161
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3887-45, LOT# L59607, IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE EXTENSION; PRODUCT ID 7434-E, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD NOT HAD HER IMPLANTABLE NEUROSTIMULATOR (INS) ON FOR AT LEAST FOUR YEARS BECAUSE IT TOUCHED THE WRONG NERVE IN HER LEG. THE PATIENT WANTED STIMULATION IN HER INNER THIGH AND IT WORKED FINE THAT WAY FOR SEVERAL YEARS. THE PATIENT WAS IN AN ACCIDENT WHERE SHE WAS REAR ENDED. A FEW WEEKS AFTER HER ACCIDENT SHE TURNED STIMULATION ON AND IT WAS NOT IN THE RIGHT AREA; SHE WAS FEELING STIMULATION IN THE FRONT PART OF HER THIGH. THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) TRIED TO REPROGRAM BUT THEY COULD NOT GET STIMULATION WHERE IT WAS SUPPOSED TO BE. IT WAS ALSO REPORTED THE PATIENT¿S NERVE PAIN WAS NOT THAT BAD ANYMORE. HER HCP ALSO WANTED TO DO SURGERY TO CORRECT SOME SPOTS IN HER SPINE AND HE WANTED TO DO AN MRI. IT WAS NOTED THE PATIENT HAD SPINA BIFIDA CULPA; HER SPINE WAS NOT OPEN BUT IT WAS CRUSHING THE NERVES ALONG HER SPINE. THE PATIENT¿S HCP WAS TRYING TO GET IT TO WHERE SHE COULD HAVE ¿HERRINGTON RODS¿ PUT IN TO STRAIGHTEN HER SPINE A LITTLE TO REDUCE THE PAIN IN HER LEGS AND HIPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302773 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR