BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTISAN

    MDR report key: 19076516 · Received April 9, 2024

    Report

    Report Number
    3006630150-2024-02195
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    May 22, 2023
    Report Date
    May 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729779919
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN BLOCK B5 AND H10 BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN MAY 2023 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216700 MODEL: SC-8216-70 SERIAL: (B)(6). BATCH: 7074508 PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: (B)(6). BATCH: 7110085 PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138350 MODEL: SC-3138-35 SERIAL: (B)(6). BATCH: 7081593 PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: (B)(6). BATCH: N/I PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138350 MODEL: SC-3138-35 SERIAL: (B)(6). BATCH: N/I

    Additional Manufacturer Narrative · 0

    EXACT DATE UNKNOWN, EVENT OCCURRED IN MAY 2023 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-PADDLE LEADS UPN: M365SC8216700 MODEL: SC-8216-70 SERIAL: (B)(6). BATCH: 7074508 PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: N/I BATCH: N/I PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: N/I BATCH: N/I PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: N/I BATCH: N/I PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: N/I BATCH: N/I.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) CLINICAL STUDY PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DURING THE TRIAL PERIOD. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE PADDLE LEADS AND LEAD EXTENSIONS WERE REMOVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE DEVICE RETURN STATUS WAS UNABLE TO BE OBTAINED DESPITE THREE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS PROVIDED THAT THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) CLINICAL STUDY PATIENT EXPERIENCED INADEQUATE PAIN RELIEF DURING THE TRIAL PERIOD. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE PADDLE LEADS AND LEAD EXTENSIONS WERE REMOVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE DEVICE RETURN STATUS WAS UNABLE TO BE OBTAINED DESPITE THREE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412210 ARTISAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-8216-70 7074455 08714729779919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention