BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1800606 · Received August 12, 2010

    Report

    Report Number
    3007566237-2010-06054
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 14, 2010
    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

    THE LEADS MIGRATED. THE IMPLANTABLE NEUROSTIMULATOR SYSTEM WAS REVISED. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC NEUROMODULATION 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention