BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8327429 · Received February 11, 2019

    Report

    Report Number
    3006630150-2019-00492
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    January 21, 2019
    Report Date
    February 11, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729784067
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5113661, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT BLOOD PRESSURE AND PULSE RATE DROPPED AND WAS CODED DURING THE TRIAL PROCEDURE. THE PHYSICIAN BELIEVED THAT THE LIDOCAINE MIGHT HAVE GOTTEN IN THE EPIDURAL SPACE. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119435 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50E 5014549 08714729784067

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention