BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 18119879 · Received November 13, 2023

    Report

    Report Number
    3006630150-2023-06973
    Event Type
    Injury
    Date Received
    November 13, 2023
    Date of Event
    August 1, 2023
    Report Date
    November 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7072208, BRAND NAME: LINEAR ST, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 5160907. BRAND NAME: LINEAR ST, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6). BATCH: 7075267.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THE LEADS PLACED IN THE EPIDURAL SPACE DUE TO LEAD MIGRATION AND EXPERIENCED A LOSS OF EFFICACY WITH THE LEADS PLACED OVER THE CLUNEAL NERVE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE PHYSICIAN REPLACED THE LEADS AND IMPLANTED NEW LEADS IN THE EPIDURAL SPACE. THE PATIENT RECOVERED WELL FROM SURGERY AND RECEIVED GOOD PAIN RELIEF WITH THE NEW LEADS. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2079826 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7072217 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention