BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD NEURO

    MDR report key: 2023101 · Received February 24, 2011

    Report

    Report Number
    3007566237-2011-01425
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 9, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    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

    RECEIVED INFORMATION WHICH STATED DURING THE IMPLANT PROCEDURE THE PHYSICIAN REMOVED THE STYLET FROM THE LEAD AND WAS THEN UNABLE TO RE-INSERT IT BACK INTO THE LEAD. A NEW LEAD WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD NEURO LGW MEDTRONIC NEUROMODULATION LEADN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1