BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18677978 · Received February 9, 2024

    Report

    Report Number
    3006630150-2024-00599
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 15, 2024
    Report Date
    February 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6). BATCH: 7133322 PRODUCT FAMILY: SCS-LEAD FIXATION UPN: M365SC43160 MODEL: SC-4316 SERIAL: (B)(6). BATCH: 31951016 PRODUCT FAMILY: SCS-LEAD FIXATION/SCS-LEAD FIXATION UPN: M365FB101010 MODEL: FB-1010-1 SERIAL: (B)(6). BATCH: 32163762/ 32358290

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LINEAR LEAD WAS REPLACED WITH A PADDLE LEAD. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60984 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7131264 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention