BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2032520 · Received March 24, 2011

    Report

    Report Number
    3007566237-2011-02261
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    January 1, 2010
    Report Date
    March 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE PATIENT HAD THEIR INS REMOVED DUE TO INFECTION. THE SYSTEM WAS REPLACED ON (B)(6) 2011. NO FURTHER INFORMATION WAS PROVIDED BUT HAS BEEN REQUESTED. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION UNKNOWN/STIM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention