BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1062906 · Received June 19, 2008

    Report

    Report Number
    2029203-2008-00389
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORP
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    SHORTLY, AFTER THE LEAD IMPLANT PROCEDURE, THE PT REPORTED HEADACHES. THE LEAD WAS EXPLANTED AND THE PT WAS TREATED WITH A BLOOD PATCH. THE PT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION SPINAL CORD STIMULATOR LEAD LGW BOSTON SCIENTIFIC NEUROMODULATION CORP SC-2138-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention