BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 20533497 · Received October 25, 2024

    Report

    Report Number
    1644487-2024-01338
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    August 28, 2024
    Report Date
    December 17, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B5: DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INFORMATION REGARDING THE PATIENT BEING SCHEDULED FOR EXPLANT WAS KNOWN PRIOR TO SUBMISSION OF THE INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    F10 HEALTH EFFECT, CLINICAL CODE: CODE E2402 UTILIZED; APPROPRIATE TERM ¿ASTHMA ¿ IS NOT AVAILABLE. LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IS NOW SCHEDULED FOR AN EXPLANT OF HER VNS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN NOTING THE CAUSE OF THE PATIENT'S VOICE ALTERATION WAS DUE TO VOCAL CORD PARALYSIS FOLLOWING VNS IMPLANT SURGERY PER AN ENT EVALUATION. THE PATIENT WAS OFFERED VOCAL FOLD INJECTIONS AS A TREATMENT OPTION TO PRECLUDE SERIOUS INJURY, WHICH WERE PLANNED TO OCCUR AFTER THE GENERATOR IS REMOVED. THE CAUSE OF THE PATIENT'S DYSPHAGIA IS VNS SURGERY AND A MODIFIED BARIUM SWALLOW TEST WAS OFFERED TO THE PATIENT, NOTED TO BE FOR COMFORT ONLY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT SHE HAS HAD NUMEROUS SIDE EFFECTS WITH THE DEVICE EVER SINCE IT WAS IMPLANTED. THE PATIENT STATED IT HAS CAUSED HER SLEEP APNEA TO WORSEN IN ADDITION TO ASTHMA. THE DEVICE WAS TURNED OFF, HOWEVER THE PATIENT STATED THESE SYMPTOMS STILL PERSISTED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED NOTING THE PATIENT'S GENERATOR WAS EXPLANTED. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR RETURN. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569645 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 206276 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Disability| O