BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3230371 · Received July 16, 2013

    Report

    Report Number
    3004209178-2013-11872
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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 MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011: PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4): PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT THE STIMULATOR HADN¿T WORKED FOR ABOUT TWO YEARS. THE PATIENT STATED THAT WHEN STIMULATION WAS TURNED ON HER RIGHT LEG WOULD GET IRRITATED AND HURT SO SHE STOPPED USING STIMULATION. IT WAS NOTED THAT THIS WAS REPORTEDLY RELATED TO A DAMAGED NERVE IN THE LEG. THE PATIENT STATED THAT SHE WANTED THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED. (B)(6) 2013: INTERFACE UPDATE: NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329879 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR