BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK X

    MDR report key: 14632715 · Received June 8, 2022

    Report

    Report Number
    3006630150-2022-02755
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 20, 2022
    Report Date
    June 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905318
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 5150893/7072323.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN ULCER IN THE BACK IN WHICH THE CLIK ANCHOR WAS PROTRUDING THE SKIN. IT WAS NOTED THAT THIS WAS FOUND OUT DURING AN IPG UPGRADE PROCEDURE AFTER THE NEW IPG WAS HOOKED UP BUT WAS NOT IMPLANTED. THE PATIENT UNDERWENT A DEVICE EXPLANT PROCEDURE. THE EXPLANTED LINEAR LEADS AND CLIK ANCHOR WERE NOT RELEASED BY THE HOSPITAL AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289022 CLIK X STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4318 24326203 08714729905318

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention