BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3200630 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11152
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 10, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3887-33, LOT# J0451703V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3887-33, LOT# J0451703V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS STILL HAVING PROBLEMS WITH THEIR SYSTEM AND THE STIMULATION WAS TOO STRONG AND MADE THE PATIENT ¿SHAKE REALLY BAD.¿ IT WAS STATED THE PATIENT¿S STIMULATION STOPPED WORKING FOUR YEARS PRIOR TO REPORT WHEN THEY TURN IT DOWN IT ¿DOESN¿T SEEM RIGHT¿ BUT WHEN THEY TURN IT UP TOO HIGH IT MAKES THEM SHAKE. IT WAS NOTED THE PATIENT FALLS A LOT, ONE TO TWO TIMES A WEEK, AND WAS UNSTABLE ON THEIR FEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298092 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR