BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1192108 · Received October 7, 2008

    Report

    Report Number
    2029203-2008-00715
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR EVALUATION, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 1

    A COMPLAINT WAS RECEIVED OF AN ABRUPT PAIN IN THE PT'S NECK AND SHOULDER WHEN HE TURNED HIS HEAD. AN ATTEMPT TO RESOLVE THE PAIN BY REPROGRAMMING THE PT WAS UNSUCCESSFUL. THE SURGEON DECIDED TO REMOVE THE PT'S LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2208-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention