BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD STYLET

    MDR report key: 2021744 · Received February 25, 2011

    Report

    Report Number
    3007566237-2011-01438
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 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). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    SEE MFR REPORT # 3007566237-2011-01437. DURING THE TRIAL THE PHYSICIAN HAD PROBLEMS WITH HIS ABILITY TO LATERALLY "FLIP" THE LEAD WITH THE UNCOATED STYLET. HE WAS UNABLE TO ROTATE IT LEFT OR RIGHT. IT WAS POOR TORQUE RESPONSE OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD STYLET LGW MEDTRONIC NEUROMODULATION STYLET/RESTORE UNK

    Patients

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