BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 16830895 · Received April 28, 2023

    Report

    Report Number
    3006630150-2023-02351
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    April 6, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 5122121/5122212.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT SCS SYSTEM IS NOT HELPING THE PAIN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN SCS SYSTEM WAS REMOVED. THE PATIENT WAS DOING FINE POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335872 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 201916 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention