BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 1150413 · Received September 5, 2008

    Report

    Report Number
    2029203-2008-00604
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE IMPLANTED IN THE PATIENT AND WILL NOT BE RETURNED FOR EVALUATION. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED PUNCTURING THE PATIENT'S DURA DURING IMPLANT SURGERY. THE PHYSICIAN TREATED THE PATIENT BY HAVING HIM LAY FLAT AND PROVIDING CAFFEINE FOR HEADACHES. THE PATIENT IS REPORTEDLY DOING WELL.

    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 ST LINEAR LEAD