BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1890216 · Received October 22, 2010

    Report

    Report Number
    3004209178-2010-08298
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    January 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A PT EXPERIENCED STIMULATION IN THE WRONG LOCATION FOLLOWING A FALL CAUSED BY A MILD STROKE. THE PT HAD FELT STIMULATION IN HER VAGINA AND STOMACH INSTEAD OF HER BACK AND LEGS. A BROKEN RECHARGER BELT WAS NOTED. THE PT'S OUTCOME WAS NOT REPORTED. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR EXPLANTED:| PROGRAMMER: MODEL 37743, LOT#: NKE114331N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT#: V115915038| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT#: V119584012