BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGABLE NEUROSTIMULATOR

    MDR report key: 1840071 · Received September 15, 2010

    Report

    Report Number
    3004209178-2010-07001
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 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

    THE PATIENT HAD NO STIMULATION SENSATION FOR 6 WEEKS. THE PATIENT HAD LOST 111 LBS AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS MOVING, BUT FELT PARALLEL AND SUPERFICIAL. THEY WERE HAVING TELEMETRY ISSUES. THE PATIENT WAS SCHEDULED FOR A REVISION BECAUSE THE INS WOULD NOT HOLD A CHARGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR IMPLANTED:| EXTENSION: MODEL #37082, LOT #NKB002162N| EXPLANTED:| PROGRAMMER: MODEL #37742, LOT #NJD034454N| LEAD: MODEL #3777, LOT #V013670| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL #37742, LOT #NJD034454N| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL #37752, LOT #NKA024019N