BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2558518 · Received May 3, 2012

    Report

    Report Number
    3004209178-2012-02946
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Report Date
    April 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377675, LOT# V005336, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-45, LOT# V078945, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT# V061945, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY USING THE PATIENT PROGRAMMER DUE TO MEDICAL LIMITATIONS. THE PATIENT HAD MINI STROKES, AND AS A RESULT HAD A HARD TIME REMEMBERING THINGS. IT WAS NOTED THAT THE PATIENT WOULD GET OUT A MANUAL AND START READING IT, BUT AFTER A WHILE HAD TO STOP AND START OVER AGAIN BECAUSE SHE COULDN'T REMEMBER WHAT SHE JUST READ. THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THE PATIENT WAS TURNING ON ALL THE BUTTONS ON THE PATIENT PROGRAMMER BECAUSE SHE COULDN'T FIGURE OUT WHAT TO DO, AND FINALLY GOT THE DEVICE TO TURN OFF. THE PATIENT WAS INSTRUCTED ON HOW TO FIRST TURN DOWN ALL THE DEVICE SETTINGS TO 0.0V USING GROUP ADJUST, THEN TURNING THE STIMULATION ON AND USING GROUP ADJUST TO INCREASE SETTINGS AGAIN. THE PATIENT WAS WALKED THROUGH EACH INDIVIDUAL PROGRAM AND INCREASED OR DECREASED LEVELS BASED ON HOW IT FELT TO THE PATIENT UNTIL THE PATIENT FELT COMFORTABLE. THESE ACTIONS RESOLVED THE REPORTED ISSUE. AT THE END OF THE CALL THE PATIENT WAS HAD STIMULATION BACK ON AND AT THE RIGHT SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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