BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2101683 · Received May 11, 2011

    Report

    Report Number
    3007566237-2011-03419
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 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 FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION THAT DURING EXPLANTATION OF THE LEAD AFTER A FAILED TRIAL (THE PATIENT DID NOT RESPOND TO STIMULATION), THE PHYSICIAN NOTED THAT THE ANCHOR WAS NOT FIXED IN THE SILICONE-SLEEVE. THE LEAD WAS FIXED IN PLACE VERY WELL AND THE ANCHOR HAD GOOD FUNCTION. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR EXPLANTED:| IMPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT # 0204762432