BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 16928995 · Received May 15, 2023

    Report

    Report Number
    3006630150-2023-02727
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    September 30, 2021
    Report Date
    May 15, 2023
    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: 7070367/7070426.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS FEELING SHOCKING SENSATION WHEN THE STIMULATOR WAS TURNED ON. THE PATIENT WAS NOT GETTING AN ADEQUATE PAIN RELIEF DESPITE REPROGRAMMING DONE. IT WAS ALSO NOTED THAT THE PATIENT WAS FEELING DISCOMFORT BY THE IPGS LOCATION. THE PATIENT UNDERWENT A DEVICE EXPLANT PROCEDURE. THE EXPLANTED IPG AND LINEAR LEADS WERE DISCARDED BY THE HOSPITAL. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257862 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 202570 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female Required Intervention