BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2061803 · Received March 30, 2011

    Report

    Report Number
    3004209178-2011-02428
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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 DEVICE WAS IN A POWER-ON-RESET CONDITION, REASON UNKNOWN. IT WAS NOTED THAT THE DEVICE WAS NOT NEAR END OF LIFE. THE OUTCOME IS UNKNOWN. FURTHER INFORMATION IS BEING REQUESTED AT THIS TIME.

    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 69 YR EXPLANTED:| EXPLANTED:| EXPLANTED:| LOT# N253789| EXTENSION: MODEL 37081, LOT# NJB075715V| LEAD: MODEL 39565-30, LOT# V483023027| IMPLANTED:| UNKNOWN CONVERSION TYPE: MODEL 3389/3550,| PROGRAMMER: MODEL 37743, LOT# NKE162603N| EXTENSION: MODEL 37081, LOT# NJB084916V| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA151194N| EXPLANTED:| IMPLANTED:| IMPLANTED: