BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8423302 · Received March 14, 2019

    Report

    Report Number
    3006630150-2019-01074
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    January 23, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    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-2218-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5093004 ; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENTS LEADS HAD MIGRATED. X-RAY REVEALED THAT ONE OF THE LEADS HAS BEEN PULLED OUT OF THE EPIDURAL SPACE. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE RELOCATED BACK INTO PLACE AND RE-ANCHORED AND THE ADDITIONAL LEAD WAS ADDED FOR ADEQUATE COVERAGE. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215213 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 21616992 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention