BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3790825 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-08526
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 14, 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
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-45, LOT # V474739, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3487A-45, LOT # V472477, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3776-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WOULD SHAKE AND HIS LEGS ¿WOULD BE BOUNCING.¿ THE REPORTER STATED THAT THEY DIDN¿T KNOW IF THE PATIENT WAS HAVING RESTLESS LEG SYNDROME, IT WAS A ¿FULL BODY THING¿ OR IF THE STIMULATOR WAS MALFUNCTIONING. IT WAS NOTED THAT THIS HAD BEEN GOING ON FOR A LITTLE WHILE AND THE PATIENT HAD BEEN GETTING ¿FULL BODY LIKE CONVULSIONS.¿ THE PATIENT¿S HEALTHCARE PROVIDER WAS CONTACTED AND DIRECTED THE PATIENT TO CONTACT THE DEVICE MANUFACTURER. THE REPORTER STATED THAT IT WAS KIND OF LIKE RESTLESS LEG SYNDROME BUT IT WAS THE FULL BODY, AND WHEN THE PATIENT CHARGED THE DEVICE IT WAS ¿HORRIBLE.¿ IT WAS NOTED THAT THE PATIENT¿S LEGS WOULD START SHAKING AND HE HAD TO GET UP AND WALK. IT WAS REPORTED THAT IT WASN¿T LIKE CONVULSIONS BUT HIS LIMBS WOULD SHAKE AND ¿BOUNCE AND BOUNCE AND BOUNCE.¿ IT WAS NOTED THAT THE PATIENT HADN¿T TURNED THE DEVICE OFF, HE LET IT DRAIN DOWN AND WHEN HE CHARGED IT, IT JUST WENT ¿CRAZY,¿ WENT ¿WAY WORSE¿ AND IT WAS TERRIBLE. IT WAS UNCLEAR WHAT THIS REFERRED TO. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267264 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