BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 12540848 · Received September 28, 2021

    Report

    Report Number
    3006630150-2021-05451
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    April 29, 2021
    Report Date
    October 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN AND INADEQUATE STIMULATION. IT WAS ALSO NOTED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT WERE PRESCRIBED WITH STEROIDS COMBINATION OF TYLENOL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED INTO NORMAL POSITION SINCE IT MOVED LATERAL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL:SC-2218-50, SERIAL: (B)(4), BATCH: 7093421. PRODUCT FAMILY: SCS-IPG-R-MRI, UPN: M365SC12160, MODEL: SC-1216, SERIAL: (B)(4), BATCH: 503865.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN AND INADEQUATE STIMULATION. IT WAS ALSO NOTED THAT THE PATIENTS LEAD HAD MIGRATED. THE PATIENT WERE PRESCRIBED WITH STEROIDS COMBINATION OF TYLENOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437085 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7093272 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention