BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 18777799 · Received February 26, 2024

    Report

    Report Number
    3006630150-2024-00965
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    February 1, 2020
    Report Date
    February 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: PATIENTS EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. B3: EXACT DATE UNKNOWN, EVENT OCCURRED FOUR YEARS AGO. D6B: 2020. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2208500. MODEL: SC-2208-50. SERIAL: (B)(6). BATCH: 203121/203589.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN ALL DEVICE COMPONENTS WERE REMOVED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298546 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 182361 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention