BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 16702008 · Received April 7, 2023

    Report

    Report Number
    3006630150-2023-01869
    Event Type
    Injury
    Date Received
    April 7, 2023
    Date of Event
    March 20, 2023
    Report Date
    April 7, 2023
    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
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    APPROXIMATED 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: M365SC2366700. MODEL: SC-2366-70 . SERIAL: (B)(4). BATCH: 7072937.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD HIGH IMPENDENCES AND IT WAS ALSO NOTED THAT ONE OF THE PATIENTS LEADS MIGRATED. THE PATIENT UNDERWENT REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED AND STILL IMPLANTED IN PATIENTS BODY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520164 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7072926 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention