BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 2173405 · Received July 23, 2011

    Report

    Report Number
    3006630150-2011-01117
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL#:SC-2218-50 SERIAL#: (B)(4) MODEL DESCRIPTION: ST LINEAR LEAD, 50CM WITH PRE-LOADED 0.014 INCH STYLET.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE PATIENT'S LEAD REVISION FOR INADEQUATE THERAPY THE PHYSICIAN PUNCTURED THE DURA. THE PHYSICIAN TREATED THE PATIENT WITH A BLOOD PATCH AND THE PATIENT WAS REPORTEDLY DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention