BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 11693935 · Received April 20, 2021

    Report

    Report Number
    3006630150-2021-01671
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    February 5, 2021
    Report Date
    April 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED SINCE THE MOTOR VEHICULAR ACCIDENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 5160484/7073609.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS WAS EXPERIENCING PAIN, INADEQUATE AND STIMULATION TO NON-TARGET AREAS. IT WAS ALSO REPORTED THAT THE LEADS MIGRATED WHICH WAS ALSO CONFIRMED IN X-RAY. THE PHYSICIAN COULD NOT SAY FOR CERTAIN IF THE MVA (MOTOR VEHICULAR ACCIDENT) WAS THE CAUSE OF THE PATIENTS SYMPTOMS AND BELIEVED THAT THEY WERE NOT DEVICE RELATED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN A LEAD WAS EXPLANTED, AND THE OTHER LEADS WERE REPOSITIONED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED LEAD WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595778 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5164077 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention