BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 9107313 · Received September 23, 2019

    Report

    Report Number
    3006630150-2019-05242
    Event Type
    Injury
    Date Received
    September 23, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-70, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5063139, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT DURING THE IMPLANT PROCEDURE, THE PATIENTS DURA WAS PUNCTURED AND CEREBROSPINAL FLUID (CSF) LEAKED WHILE PLACING THE LEAD. THE PATIENT COMPLAINED OF A SPINAL HEADACHE POSTOPERATIVELY AND WAS GIVEN INTRAVENOUS (IV) CAFFEINE AS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899151 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5103031 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention