BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK

    MDR report key: 20045272 · Received August 23, 2024

    Report

    Report Number
    3006630150-2024-05541
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    August 1, 2024
    Report Date
    January 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729793267
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS, UPN: M365SC8216700, MODEL: SC-8216-70, SERIAL: (B)(6), BATCH: 7071813.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE CLIK ANCHOR SITE AND HAD AN INJECTION WITH NO RELIEF. NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS CLIK ANCHOR AND PADDLE LEAD WAS BECOMING SUPERFICIAL. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE CLIK ANCHOR AND PADDLE LEAD WAS PLACED DEEPER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE CLIK ANCHOR SITE AND HAD AN INJECTION WITH NO RELIEF. NO FURTHER COURSE OF ACTION WILL BE TAKEN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742902 CLIK STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-4316 22128460 08714729793267

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention| O