BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1961116 · Received January 12, 2011

    Report

    Report Number
    3004209178-2011-00300
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING THE RESTORE INS WAS ON THE VERGE OF ERUPTING THROUGH THE PT'S SKIN. IT WAS REPLACED WITH THE ULTRA INS TO AVOID FURTHER IRRITATION. THE PT RECOVERED WITHOUT SEQUELA.

    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 65 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 37081, LOT #: NJB017003V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-30, LOT #, N112184004| IMPLANTED:| ACCESSORY: MODEL 37752, LOT #: NKA131255N| PROGRAMMER: MODEL 37742, LOT #: NJD054597N| EXPLANTED:| EXTENSION: MODEL 37081, LOT #: NJB019733V| IMPLANTED: