BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1980369 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00855
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    January 19, 2010
    Report Date
    January 19, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT FELL OVER ON THE MOTORCYCLE AND STRUCK THE AREA ABOVE THE IMPLANTABLE NEUROSTIMULATOR SITE. A YEAR LATER, THE PT WAS SEEN IN CLINIC BY A FIELD REP. HE FELT NO STIMULATION USING PROGRAM 2. THE THERAPY IMPEDANCE WAS HIGH OUT OF RANGE; THE CURRENT WAS LOW. THE PT DID NOT NORMALLY USE PROGRAM 2. PROGRAM 1 ALSO REVEALED HIGH OUT OF RANGE THERAPY IMPEDANCES. ALL BUT 3 BIPOLAR ELECTRODE IMPEDANCES WERE HIGH OUT-OF-RANGE. THE PT FELT SOME STIMULATION, BUT NOT LIKE IT USED TO BE. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR PROGRAMMER: MODEL 37742, LOT# NJD043794N| IMPLANTED:| RECHARGER: MODEL 37752, LOT# NKA018975N| EXPLANTED:| LEAD: MODEL 3777, LOT# V006891| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V006891