BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 19431949 · Received May 30, 2024

    Report

    Report Number
    3006630150-2024-03516
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    May 7, 2024
    Report Date
    May 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 7071914. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 7071604. PRODUCT FAMILY: SCS-EXTENSION. UPN: M365SC3138250. MODEL: SC-3138-25. SERIAL: (B)(6). BATCH: 7072463.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT EXPERIENCED PAIN AT THE LEAD EXTENSION SITE. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE LEAD EXTENSIONS WERE EXPLANTED AND REPLACED. THE PATIENT WAS RECOVERING WELL WITH NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED LEAD EXTENSIONS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453597 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-3138-25 7071596

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention