BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 21340980 · Received February 9, 2025

    Report

    Report Number
    3006630150-2025-00580
    Event Type
    Injury
    Date Received
    February 9, 2025
    Date of Event
    January 16, 2025
    Report Date
    February 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: M365SC2138500, MODEL: SC-2138-50, SERIAL: (B)(6), BATCH: A10561 / 117679.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL CORD STIMULATION (SCS) SYSTEM EXPLANT PROCEDURE DUE TO AN UNKNOWN REASON. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97540 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-1110-02 13568864 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention