BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15084529 · Received July 22, 2022

    Report

    Report Number
    3006630150-2022-03615
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    May 31, 2022
    Report Date
    August 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2208500, MODEL: SC-2208-50, SERIAL: (B)(4), BATCH: 180545.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION DUE TO HIGH IMPEDANCE ON THE LEADS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION DUE TO HIGH IMPEDANCE ON THE LEADS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE RETAINED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80863 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2208-50 180534

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention