BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION®

    MDR report key: 3042804 · Received April 9, 2013

    Report

    Report Number
    3006630150-2013-00647
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL #: SC-2218-70 SERIAL/LOT #: (B)(4), DESCRIPTION: LINEAR ST LEAD, 70CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING HEADACHE DUE TO A DURA TEAR DURING AN IMPLANT PROCEDURE. THE PATIENT WAS GIVEN A BLOOD PATCH AND THE HEADACHE WAS REPORTEDLY GONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146749 PRECISION® SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention