BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 16884087 · Received May 8, 2023

    Report

    Report Number
    3006630150-2023-02555
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    January 10, 2023
    Report Date
    May 8, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(4). BATCH: 7072687.

    Additional Manufacturer Narrative · 0

    BLOCK B3: 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: M365SC2317500. MODEL: SC-2317-50. SERIAL: (B)(4). BATCH: 7072687.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE AND LOSS OF STIMULATION DUE TO LEAD MIGRATION WHICH WAS CONFIRMED THRU X-RAY. THE PATIENT WAS REPROGRAMMED BUT RENDERED THE SAME RESULT. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE LEADS WERE REMOVED. THE EXPLANTED LEADS WERE NOT RELEASED FROM THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE AND LOSS OF STIMULATION DUE TO LEAD MIGRATION WHICH WAS CONFIRMED THRU X-RAY. THE PATIENT WAS REPROGRAMMED BUT RENDERED THE SAME RESULT. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE LEADS WERE REMOVED. THE EXPLANTED LEADS WERE NOT RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1902106 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7081187 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention