BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 1900515 · Received October 28, 2010

    Report

    Report Number
    3004209178-2010-08558
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 30, 2010
    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

    IT WAS REPORTED PATIENT STATED THE BATTERY WAS TURNING OFF WITHOUT CONTROLLER. IT WAS NOTED THIS HAD OCCURRED FOR APPROXIMATELY TWO WEEKS. IT WAS NOTED NO SCHEDULED THERAPY WAS ACTIVE. CURRENT IMPEDANCE MEASUREMENTS WERE REVIEWED AND ARE NORMAL. LONGEVITY CALCULATION WAS PERFORMED TO ESTIMATE IMPLANTABLE NEURO STIMULATOR (INS) BATTERY LIFE. PATIENT FIRST STATED SHE CHARGED INS EVERY 6 WEEKS. HOWEVER, CALCULATION INDICATED A NEED TO CHARGE (BOL 22.7 DAYS AND EOL 10.8 DAYS - ESTIMATED APPROX. 15-16 DAY RECHARGE REQUIREMENT). IT WAS DISCUSSED WITH PATIENT TO KEEP A DIARY. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    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 49 YR IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD022196N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC007768N| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3887, LOT# N23426| EXTENSION: MODEL 37083, LOT# NKC007769N| EXPLANTED:| LEAD: MODEL 3887, LOT# N23426| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA020965N| EXPLANTED: