BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL STIMULATOR

    MDR report key: 1983025 · Received February 4, 2011

    Report

    Report Number
    3007566237-2011-00901
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    October 1, 2010
    Report Date
    January 20, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO A TRIAL PT HAD EXCESSIVE BLEEDING FROM THE INCISION ON HIS BACK THAT REQUIRED MEDICAL ATTENTION. PT ALSO REPORTED A SHOCKING AND THUMPING SENSATION WHEN THE STIMULATION WAS TURNED ON. PT DID NOT GO ON TO FULL IMPLANT. HE HAS RECOVERED FROM THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL STIMULATOR LGW MEDTRONIC NEUROMODULATION 37022 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention