BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2974798 · Received February 22, 2013

    Report

    Report Number
    3004209178-2013-02993
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Report Date
    February 1, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT STIMULATION AND "SHOCKING" SENSATIONS. THE PATIENT REPORTED THAT WHILE THE STIMULATION WAS ON, THAT IT FELT "AS THOUGH STIMULATION WAS SHUTTING OFF AND THEN COMING ON AGAIN RANDOMLY." THE PATIENT NOTED THAT THE STIMULATION SENSATION WOULD BE LOST WHILE WALKING AND THEN "HE WOULD FEEL IT AGAIN." THE PATIENT ADDITIONALLY NOTED THAT THE INTERMITTENCY WAS OF "RECENT ONSET." IT WAS ALSO NOTED THAT THE SHOCKING SENSATION WAS ONLY FELT WHEN STIMULATION WOULD COME BACK ON. IT WAS REPORTED THAT AN IMPEDANCE TEST "SHOWED NOTHING OUT-OF-RANGE." AN X-RAY WAS PERFORMED SIX DAYS PRIOR TO REPORT WHERE "EVERYTHING LOOKED INTACT." IT WAS NOTED THAT THE INTERMITTENCY "DIDN'T APPEAR RELATED TO POSTURAL CHANGES." THE PATIENT CONTINUED TO GET "GREAT COVERAGE" AT THE TIME OF REPORT. ADDITIONAL INFORMATION WAS REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77886 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1