BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2081542 · Received April 19, 2011

    Report

    Report Number
    3004209178-2011-02922
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 30, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A FALL, THE PT HAD A LOSS OF THERAPEUTIC EFFECT AND INCREASED PAIN. THE PT FELL FORWARD ON THE ICE ABOUT A MONTH PRIOR TO THE REPORTED ISSUES. THE PT HAD ACUTE PAIN IN HER RIGHT SHOULDER BLADE AS WELL AS ARM WEAKNESS. THE PATIENT'S LEFT ARM WAS ALSO LIMP AND IMMOBILE. THE PT HAD SPASMS IN HER UPPER BACK. THE PT ALSO HAD HEADACHES AND URINARY ISSUES. THE PT ATTEMPTED TO INCREASE STIMULATION WITH NO AFFECT ON THE PAIN. THE PT MET WITH A COMPANY REP AND HER PHYSICIAN, BUT THE ISSUES REMAINED. ADD'L INFO HAS BEEN REQUESTED.

    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 47 YR EXTENSION: MODEL 37081, LOT# NJB083655V| LEAD: MODEL 3778, LOT# V550379012| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB083646V| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V550379011| ACCESSORY: MODEL 37752, LOT# NKA147064N| PROGRAMMER: MODEL 37743, LOT# NKE158404N| IMPLANTED:| IMPLANTED:| IMPLANTED: