BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD LOW IMPEDANCE LEAD

    MDR report key: 1993788 · Received January 13, 2011

    Report

    Report Number
    3007566237-2011-00331
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Report Date
    January 3, 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

    THE STYLET STUCK DURING INSERTION. THE DOCTOR HAD A DIFFICULT TIME INSERTING THE STYLET BACK INTO THE LEAD WHEN THE LEAD WAS ALREADY IN THE EPIDURAL SPACE. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD LOW IMPEDANCE LEAD LGW MEDTRONIC NEUROMODULATION 3777 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 STIM ACCESSORY: MODEL STYLET/RESTORE, LOT# UNK| IMPLANTED:| EXPLANTED: