BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 1111638 · Received August 13, 2008

    Report

    Report Number
    2182207-2008-04927
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    April 25, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD AND SCREENING CABLE WERE RETURNED TO THE MFR FOR ANALYSIS ON 05/19/2008. FINAL DEVICE ANALYSIS OF THE LEAD REVEALED THAT THE #4 AND #6 CONDUCTORS WERE BROKEN AT THE PROXIMAL END OF THE #3 CONNECTOR. OVERSTRESS DAMAGE WAS SUSPECTED. ANALYSIS OF THE SCREENING CABLE REVEALED NO ANOMALY. THE CABLE WAS FUNCTIONALLY OK. CABLE ANALYSIS CODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO RESPONSE WHEN TRAILING THE LEAD AT THE IMPLANT SURGERY. THE SCREENING CABLE WAS EXCHANGED FIRST WITH NO RESPONSE. THE LEAD WAS CHANGED AND STIMULATION WAS ACHIEVED. THE IMPLANTABLE NEUROSTIMULATOR WAS CONNECTED WITH THE NEW LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL NEUROSTIMULATOR LGW MEDTRONIC NEUROMODULATION 37021 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STIM ACCESSORY MODEL 3550-31| LEAD MODEL 3777| IMPLANTED| EXPLANTED| EXPLANTED| IMPLANTED