BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 1823437 · Received August 25, 2010

    Report

    Report Number
    3007566237-2010-06445
    Event Type
    Injury
    Date Received
    August 25, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    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 FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    NO STIMULATION SENSATION DURING A TRIAL IMPLANT WAS REPORTED, AND HIGH IMPEDANCE READINGS WERE > 10,000 OHMS. THE LEAD WAS THEREFORE NOT USED IN THE PT, AND ANOTHER ONE WAS IMPLANTED IN ITS PLACE. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STIM ACCESSORY: MODEL STYLET/RESTORE, LOT # UNK| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3874, LOT # V490797| IMPLANTED:| EXPLANTED: