BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 11283506 · Received February 4, 2021

    Report

    Report Number
    3006630150-2021-00301
    Event Type
    Injury
    Date Received
    February 4, 2021
    Date of Event
    January 9, 2021
    Report Date
    February 4, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON THE UNKNOWN SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), LOT: 5030340. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-50, SERIAL: (B)(4), LOT: 5058298.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED ADDITIONAL COVERAGE IN HIS FEET AS HE WAS EXPERIENCING INADEQUATE STIMULATION. AS A RESULT, THE PATIENT HAD AN ADDITIONAL LEAD IMPLANTED TO IMPROVE THERAPY. THE SYSTEM REMAINS IMPLANTED AND CANNOT BE RETURNED FOR ANALYSIS. THE PATIENT IS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177293 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 20786582 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention