BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 1940575 · Received December 17, 2010

    Report

    Report Number
    3007566237-2010-10565
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    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 LEAD IMPEDANCE MEASUREMENT WERE GREATER THAN 10,000 OHMS DURING TRIAL IMPLANT SURGERY. TWO MULTI-LEAD TRIALING CABLES, AN OLD SNAPLID, AND A DIFFERENT 8840 WERE USED WITH CONTINUED IMPEDANCE ISSUES. THE LEAD WAS GOING TO BE REPLACED. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# UNKNOWN