BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2230572 · Received August 12, 2011

    Report

    Report Number
    3004209178-2011-06291
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    May 1, 2011
    Report Date
    August 4, 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
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COULD NOT FEEL A STIMULATION SENSATION; HOWEVER, SHE FELT OVERSTIMULATION ONLY WHEN LEANING BACK. POSITIONAL CHANGES CAUSED CHANGES IN STIMULATION. THE PT ALSO EXPERIENCED INCREASED PAIN IN HER LOWER LEFT EXTREMITIES. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. THE PT WAS AT HOME IN FAIR CONDITION. ADDITIONAL INFO RECEIVED REPORTED HIGH IMPEDANCES OVER 3,600 OHMS ON CONTACTS 1&0. THE LEAD WAS REVISED ON (B)(6) 2011. THE PT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT.

    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 59 YR Required Intervention LEAD: MODEL 3888, LOT # J0316202V| EXPLANTED:| EXTENSION: MODEL 37083, LOT # NKC012169N| PROGRAMMER: MODEL 37742, LOT # NJD063192N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA037115N| IMPLANTED:| IMPLANTED: