BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 16018841 · Received December 20, 2022

    Report

    Report Number
    3006630150-2022-07146
    Event Type
    Injury
    Date Received
    December 20, 2022
    Date of Event
    November 26, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500; MODEL: SC-2366-50; SERIAL: (B)(4); BATCH: 7073074. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500; MODEL: SC-2366-50; SERIAL: (B)(4); BATCH: 7073075. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2366500; MODEL: SC-2366-50; SERIAL: (B)(4); BATCH: 7073094.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO THEIR SPINAL CORD STIMULATION (SCS) LEAD MIGRATING. THE PATIENT'S DEVICE WAS REPROGRAMMED, HOWEVER, THE REPORTED ISSUE PERSISTED. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE WHERE THEIR DEVICES WERE EXPLANTED. THE PATIENT IS REPORTEDLY RECOVERING. THE DEVICES WERE DISCARDED AND NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455660 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7073025 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention