BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 17800487 · Received September 22, 2023

    Report

    Report Number
    1644487-2023-01379
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    August 29, 2023
    Report Date
    November 26, 2025
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 #34;DEFECTS¿ OR #34;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

    IT WAS REPORTED THAT THE PATIENT #39;S BATTERY LEVEL HAS DEPLETED SOONER THAN EXPECTED. WHEN THE PATIENT WAS LAST SEEN THE BATTERY LEVEL WAS OBSERVED OK. THE GENERATOR WAS RECENTLY INTERROGATED AND THE BATTERY LEVEL IS NOW READING AT A MUCH LOWER PERCENTAGE. A SESSION REPORT FROM THE VISIT WAS PROVIDED: IMPEDANCE 2753 OHMS / BATTERY 11-25%; NORMAL OUTPUT CURRENT - 2MA / FREQUENCY - 30HZ / PULSE WIDTH - 500USEC / ON TIME - 30S / OFF TIME - 3 MIN / MAGNET OUTPUT CURRENT ¿ 2.25MA / MAGNET PULSE WIDTH - 500USEC / MAGNET ON TIME - 60S/ AUTOSTIM OUTPUT CURRENT - 2.25MA / AUTOSTIM PULSE WIDTH - 500USEC / AUTOSTIM ON TIME - 30S. THE DEVICE HISTORY RECORDS OF THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    UPDATE WAS RECEIVED THAT THE BATTERY LEVEL WAS SEEN OK AND THEN LOW AGAIN. THE PATIENT WAS REFERRED FOR A GENERATOR REPLACEMENT. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IMPLANT CARD WAS RECEIVED REPORTING THAT THE GENERATOR WAS REPLACED. THE SUSPECT DEVICE HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE SUSPECT DEVICE WAS RECEIVED FOR ANALYSIS. ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS PERFORMED. THE ANALYSIS DID NOT FIND ANY ANOMALIES WITH THE SUSPECTED DEVICE. THE GENERATOR PREFORMED AS EXPECTED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1974903 PULSE GEN MODEL 106 GENERATOR LYJ CYBERONICS - HOUSTON 106 206056 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male