BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1890159 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08255
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    July 1, 2010
    Report Date
    September 27, 2010
    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
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS "HAVING TROUBLE." THE PT HAD "UNUSUAL" PAIN IN THE MID BACK AROUND WHERE THE SURGERY WAS DONE. THE PREVIOUS WEEK, THE PT EXPERIENCED VERTIGO. THE PT'S PAIN WAS "STABBING AND STRIKING," THE PT'S LEG FELT "LIKE RUBBER" AND WOULD SOMETIMES SHAKE INVOLUNTARILY. THE SYMPTOMS STARTED APPROX FIVE DAYS AGO. THE PT WAS BENDING OVER AND WENT TO STRAIGHTEN UP WHEN HE YELLED OUT IN PAIN AND COULD NOT STAND UP. AT THAT POINT, THE PT'S LEGS STARTED SHAKING. THE PT'S STATUS WAS "FAIR." ON A LATER DATE, IT WAS REPORTED THAT NO EFFICIENCY BARS WERE SHOWN AND THE DEVICE WOULD NOT CHARGE ABOVE 25%. THE PT HAD A FALL DUE TO A VERTIGO EPISODE, AND SINCE THEN, THE DEVICE "POKES OUT OF THE SKIN" AND GETS ZERO COUPLING BARS. ALSO AFTER THE FALL, THE PT HAD EXPERIENCED SHOCKING SENSATIONS. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR EXPLANTED:| PROGRAMMER: MODEL 37743, LOT #: NKE141140N| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT #: V032601021| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT #NKA135516N| EXPLANTED: