BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1067207 · Received June 30, 2008

    Report

    Report Number
    2029203-2008-00436
    Event Type
    Injury
    Date Received
    June 30, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A TRIAL LEAD PROCEDURE, THE PT SHOWED SIGNS OF A DURA PUNCTURE. THE SURGEON EXPLANTED THE LEADS AND ABORTED THE PROCEDURE. 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-2138-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention