BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 19534560 · Received June 13, 2024

    Report

    Report Number
    3006630150-2024-03835
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    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

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS)INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-6, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7070381 AND 7070471.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS' LEADS OF THE SPINAL CORD STIMULATOR (SCS) MIGRATED. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE LEADS WERE REPOSITIONED. IT IS UNKNOWN IF THE PATIENT EXPERIENCED AN EFFECTS FROM THE LEAD MIGRATION AS THE PHYSICIAN DOES NOT RELEASE PATIENT INFORMATION. THE PATIENT IS DOING WELL POST OPERATIVELY. NO DEVICES WILL BE RETURNED AS THEY ALL REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153438 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7070346 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention