BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 2211130 · Received August 8, 2011

    Report

    Report Number
    3004209178-2011-06134
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    April 29, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC 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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS DEPLETED. THE HCP FELT THE BATTERY SHOULD BE CHECKED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD022653N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC006550N| ACCESSORY: MODEL 37752, LOT# NKA028683N| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N077909| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT# J0019916V