BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 14091710 · Received April 13, 2022

    Report

    Report Number
    3006630150-2022-01612
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 12, 2022
    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

    DATE OF EVENT: 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)(4), BATCH: 7073288 / 7073290.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE STIMULATION DESPITE MULTIPLE REPROGRAMMING ATTEMPTS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED IPG AND LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939556 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 204063 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Required Intervention