BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3113638 · Received May 15, 2013

    Report

    Report Number
    3007566237-2013-01619
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEMATOMA WAS INITIALLY CAUSED BY THE UNKNOWN RESUME LEAD. THIS INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURE REPORT # 3007566237-2012-03117. BUT ADDITIONAL REVIEW REVEALED THAT IT REQUIRED IT'S OWN EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215515 UKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention