BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3751655 · Received April 15, 2014

    Report

    Report Number
    3004209178-2014-07246
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Report Date
    March 25, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377860, LOT# V011889, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377860, LOT# V011816, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HIS THERAPY OR DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING TROUBLE GETTING CHARGE AT ONE POINT BUT AT THE TIME OF REPORT IT SEEMED TO BE BETTER. IT WAS LOGGED THE PATIENT WOULD ALSO TURN HIS DEVICE OFF EVERY NIGHT AND SOMETIMES HE WOULD WAKE UP AND IT WOULD BE ON. IT WAS NOTED THIS WAS ALSO HAPPENING DURING THE DAY, THAT THE DEVICE WOULD TURN ON, ON IT'S OWN. IT WAS NOTED THAT THE PATIENT WAS USING THE ON AND OFF BUTTONS APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229890 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR