BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK

    MDR report key: 17397854 · Received July 26, 2023

    Report

    Report Number
    3006630150-2023-04370
    Event Type
    Injury
    Date Received
    July 26, 2023
    Date of Event
    July 6, 2023
    Report Date
    July 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7088252, 7091851.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING EXTRUSION OF THE CLICK ANCHOR. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING LEAD MIGRATION. NO DEVICE MALFUNCTION SUSPECTED. THE PATIENT UNDERWENT EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED PRODUCTS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661281 CLIK STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4316

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention