BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8819928 · Received July 23, 2019

    Report

    Report Number
    3006630150-2019-03783
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    January 2, 2019
    Report Date
    July 23, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5082686, MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION IN BOTH FEET. X-RAY REVEALED THAT THE LEADS ARE LOCATED AT THE TIP OF THE BASE OF SEVENTH THORACIC VERTEBRA. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE RELOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611675 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5082505 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention