BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17341729 · Received July 18, 2023

    Report

    Report Number
    3006630150-2023-04183
    Event Type
    Injury
    Date Received
    July 18, 2023
    Date of Event
    April 23, 2023
    Report Date
    July 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED ABOUT TWO MONTHS AGO, 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: M365SC2218500, MODEL: SC-2218-550, SERIAL: (B)(6), BATCH: 7083310.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS WERE HAVING HIGH IMPEDANCES OF ONE IN ITS LEADS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEADS WERE REPLACED AND WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765421 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7083308 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Required Intervention