BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 11276311 · Received February 3, 2021

    Report

    Report Number
    1644487-2021-00150
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 8, 2021
    Report Date
    April 5, 2021
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    MUZ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIBE EVENT OR PROBLEM - CORRECTION - "THE PATIENT WAS ALSO EXPERIENCING INCREASED DEPRESSION AND WAS ADVISED TO GO TO THE ER." WAS NOT INCLUDED IN INITIAL MDR F10. ADVERSE EVENT PROBLEM - HEALTH EFFECT - CORRECTION - CODE E233001 WERE INADVERTENTLY NOT INCLUDED IN THE INITIAL MDR.

    Description of Event or Problem · 0

    NO KNOWN SURGERY HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED WHEN THAT OCCASIONALLY WITH STIMULATION THE PATIENT THROAT AND UPPER BRONCHIAL CONSTRICT MAKING IT DIFFICULT TO BREATH. PATIENT WAS SEEN IN MULTIPLE ERS FOR PAINFUL STIMULATION, NAUSEA, AND DYSPNEA. THE PATIENT WAS NOTED TO EXPERIENCED COUGHING. THE PATIENT WAS REPORTED TO BE EXPERIENCING NAUSEA. THE PATIENT WAS SEEN IN CLINIC AND HER GENERATOR WAS INTERROGATED. NO DEVICE ISSUES WERE OBSERVED. DURING THE APPOINTMENT, NO COUGHING OR OTHER SYMPTOMS PREVIOUSLY REPORTED WERE OBSERVED. THE PHYSICIAN DECIDED TO PROGRAM OFF THE GENERATOR. PER THE PHYSICIAN, THE CAUSE OF THE ADVERSE EVENTS IS NOT KNOWN. PATIENT WAS OFFERED TO BE REFERRED FOR REPLACEMENT. NO KNOWN SURGERY HAS OCCURRED TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168168 PULSE GEN MODEL 106 GENERATOR MUZ LIVANOVA USA, INC. 106 4814 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR