BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 19843143 · Received July 26, 2024

    Report

    Report Number
    3006630150-2024-04883
    Event Type
    Injury
    Date Received
    July 26, 2024
    Date of Event
    June 10, 2024
    Report Date
    July 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
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218300 MODEL: SC-2218-30 SERIAL: (B)(6) BATCH: 15311239. PRODUCT FAMILY: SCS-EXTENSION UPN: M365SC3138550 MODEL: SC-3138-55 SERIAL: (B)(6) BATCH: 14736198.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED TO CHECK THE SPINAL CORD STIMULATION (SCS) SYSTEM. HIGH IMPEDANCE MEASUREMENTS WERE OBSERVED, AND THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND THE PHYSICIAN IS TAKING A WAIT AND SEE APPROACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1457681 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 15820680 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Hospitalization