BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    MDR report key: 2021801 · Received February 25, 2011

    Report

    Report Number
    3007566237-2011-01462
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Report Date
    February 10, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    IT WAS REPORTED THAT IMPEDANCES READ >3600 OHMS WHEN USING ELECTRODES 0 AND 1. IT WAS ALSO NOTED THAT THE PATIENT HAD REDUCED LEVEL OF THERAPY WITH PROGRAMMING OF ELECTRODES 2 AND 3. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE RECHARGEABLE NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 STIM ACCESSORY: MODEL 3550-29, LOT# N0047451| PROGRAMMER: MODEL 37742, LOT# NJD034956N| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N0047451| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V001706