BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3211526 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11463
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 13, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND AN INCREASE IN BASELINE PAIN. IT WAS NOTED THAT THIS OCCURRED FOLLOWING A CAR ACCIDENT ON (B)(6) 2013. THE PATIENT WAS IN THE PASSENGER SEAT OF A CAR AND WAS ¿T-BONED.¿ IT WAS NOTED THAT AFTER THE MOVING VEHICLE ACCIDENT THEIR BACK STARTED HURTING. IT WAS NOTED THAT THE PATIENT TRIED USING THE RECHARGER. IT WAS FURTHER NOTED THAT THE RECHARGER COMMUNICATES, ¿BUT IT IS NOT CHARGING.¿ IT WAS NOTED THAT THE PATIENT WONDERED IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿SHIFTED OR A CORD GOT PULLED.¿ IT WAS NOTED BY THE PATIENT THAT THE PROGRAMMER DID NOT COMMUNICATE WITH THE INS. IT WAS NOTED THAT THE SCREEN JUST SHOWED AN EMPTY DEVICE. THE REPORTER STATED THAT ¿IT WAS WORKING FINE AND NOW IT WAS NOT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308750 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR