BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 18731612 · Received February 19, 2024

    Report

    Report Number
    3006630150-2024-00801
    Event Type
    Injury
    Date Received
    February 19, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(6), BATCH: 7071472/7071474.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INADEQUATE STIMULATION. ALL EXPLANTED DEVICE COMPONENTS WILL NOT BE RETURNED AS THEY WERE KEPT BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403202 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 203304 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention