BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK

    MDR report key: 20027676 · Received August 22, 2024

    Report

    Report Number
    3006630150-2024-05404
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729793267
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218500 MODEL: SC-2218-50 SERIAL: (B)(6) BATCH: 7143730/7146264.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS MID BACK ANCHOR INCISION SITE HAD SOME DRAINAGE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE EXPLANTED DEVICES WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1116512 CLIK STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4316 33778732 08714729793267

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention