BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2093026 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-03212
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Report Date
    April 21, 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).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED NO STIMULATION SENSATION EVEN WHEN TURNING THE INS UP TO 10.5V AND AFTER REPROGRAMMING. SHE HAS NOT CHARGED HER DEVICE SINCE (B)(6). THE MESSAGE "CALL YOUR DOCTOR" ICON DISPLAYED, ERROR CODE 376. HER INS WAS OVER-DISCHARGED BUT WAS ABLE TO GET IT OUT OF IT. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 3,600 OHMS WITH ELECTRODES 6 AND 15. THE REST OF THE ELECTRODES WERE WITHIN RANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V241889011| PROGRAMMER: MODEL 37743, LOT# NKE127731N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA128662N| LEAD: MODEL 3777, LOT# V229258036| ACCESSORY: MODEL 37791, LOT# UNK