BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3901618 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12249
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 5, 2014
    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

    PRODUCT ID 37791, SERIAL# UNKNOWN; PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED STIMULATION WAS TURNING ON. IT WAS NOTED THE PATIENT¿S STIMULATION WAS ON AND WOULD NOT TURN OFF. IT WAS REPORTED, THE PATIENT¿S PROGRAMMER NEEDED NEW BATTERIES. IT WAS NOTED, THE PATIENT WAS ABLE TO TURN STIMULATION OFF WITH THE RECHARGER. IT WAS REPORTED THE PATIENT HAD NOT USED STIMULATION IN A COUPLE OF WEEKS. IT WAS REPORTED, THE PATIENT¿S STIMULATION TURNED ON, WOULD NOT TURN OFF, AND THEN TURNED OFF SUDDENLY DURING RECHARGE THE NIGHT PRIOR TO CALL. IT WAS NOTED, THE PATIENT DID NOT KNOW THE FUNCTION OF THE SIDE KEYS AND DID NOT THINK THEY PRESSED THE BUTTONS. IT WAS REPORTED THE PATIENT DID PRESS THE GRAY BUTTON, BUT STIMULATION DID NOT TURN OFF. IT WAS NOTED THE PATIENT HAD A COUPLING PROBLEM. IT WAS REPORTED THE RECHARGER ANTENNA WAS DAMAGED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GIVEN THE NAME OF A HEALTH CARE PROFESSIONAL BUT STILL HAD NOT HAD AN APPOINTMENT WITH HIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379431 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 00082 YR