BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2052647 · Received April 7, 2011

    Report

    Report Number
    3004209178-2011-02671
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD BEEN HIT AT THE DEVICE POCKET BY A SHOPPING CART AT THE BEGINNING OF (B)(6) 2011. THE PATIENT WAS FEELING STIMULATION FOLLOWING THE EVENT, BUT WAS UNABLE TO RECHARGE DUE TO THE SWELLING. THE PATIENT WAS SEEN BY THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2011 AS SHE NO LONGER FELT STIMULATION AND THE DEVICE WAS UNRESPONSIVE TO ANY TELEMETRY. THE HCP CONDUCTED A PHYSICIAN MODE RECHARGE (PMR) TO ELICIT A POWER ON RESET (POR) TO OCCUR. THE PATIENT WAS THEN ABLE TO RECHARGE THE DEVICE TO 100%. THE PATIENT REPORTED A "CALL YOUR DOCTOR" MESSAGE WHILE CHARGING AND THE DEVICE WAS DELETED THE FOLLOWING DAY, (B)(6) 2011. ON (B)(6) 2011, THE PATIENT CALLED EMERGENCY SERVICES TO HER HOME DUE TO EXTREME PAIN, SPASMS IN HER ARMS AND UPPER BODY. THE PATIENT WAS BEING SHOCKED BY THE DEVICE AND COULD NOT TURN IT OFF. THE PATIENT WAS GIVEN VALIUM. THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM AND INTERROGATION SHOWED THE DEVICE WAS OFF, ALTHOUGH THE PATIENT WAS CLEARLY BEING OVERSTIMULATED AS HER ARMS WERE THRASHING. THE DEVICE WAS TOGGLED ON AND THE PATIENT IMMEDIATELY NOTICED A DECREASE IN HER PAIN. THE DEVICE WAS THEN TURNED OFF AND THE PATIENT WAS MUCH MORE COMFORTABLE AFTER THE DEVICE WAS TURNED OFF. THE PATIENT NOTED SHE WAS ABLE TO FEEL THE STIMULATION TURN OFF AND RELAX. THE POR APPEARED TO STILL BE IN PLACE UPON INTERROGATION WHILE THE PATIENT WAS RECEIVING UNCOMFORTABLE STIMULATION, ALTHOUGH NO STIMULATION WOULD BE DELIVERED IF THE DEVICE IS IN A POR STATE. THE PATIENT HAD AN APPOINTMENT WITH THE HCP ON (B)(6) 2011 TO DISCUSS OPTIONS INCLUDING SYSTEM EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB038100V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB038099V| EXPLANTED:| LEAD: MODEL 3776, LOT# V134161011| LEAD: MODEL 3776, LOT# V134161012| PROGRAMMER: MODEL 37743, LOT# NKE114914N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA117994N