BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 15107773 · Received July 26, 2022

    Report

    Report Number
    1644487-2022-00910
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    June 30, 2022
    Report Date
    September 23, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750061
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    117

    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 "DEFECTS¿ OR "MALFUNCTIONS¿. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Additional Manufacturer Narrative · 0

    B5. CORRECTED DESCRIPTION OF EVENT, SUPPLEMENTAL #1 REPORT: INADVERTENTLY LEFT OUT CONCLUSION. B6. CORRECTED DATA, SUPPLEMENTAL #1 REPORT: SHOULD HAVE OMITTED INCORRECT FORMULA AND CALCULATION FOR NON LASER-ROUTER GENERATOR: "ON 06/22/2022, THE PBCR USING HISTORY WAS 59.562 AND THE PBCR USING VBAT WAS 24.812. PER THE EQUATION, VBAT = 3.518778 + (59.562)*0.44567 = 30.063775 VERSUS 24.812 MEASURED ¿PBCR USING VBAT¿ ON THE DECODER. SINCE THE MEASURED VBAT ON THE DECODER IS LOWER THAN WHAT THE FORMULA GIVES, THE DEVICE IS BELOW THE 95% PREDICTION INTERVAL AND THIS IS EVIDENCE THAT THE BATTERY IS DEPLETING FASTER THAN EXPECTED." H6. CORRECTED INVESTIGATION FINDINGS, INITIAL REPORT: INADVERTENTLY PUT C19 INSTEAD OF C20. H6. CORRECTED INVESTIGATION FINDINGS, SUPPLEMENTAL #1 REPORT: INADVERTENTLY PUT C20 INSTEAD OF C19.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S GENERATOR WAS DEPLETING RAPIDLY. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR. THE GENERATOR PASSED ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. THE GENERATOR WAS HP STERILIZED. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PROVIDER CONFIRMED THAT THEY BELIEVE THE PATIENT'S GENERATOR IS DEPLETING PREMATURELY. INTERNAL DATA WAS ALSO RECEIVED AND REVIEWED.

    Description of Event or Problem · 0

    THE 25% INDICATOR WAS DISPLAYED DUE TO THE EFFECT OF THE HIGH SETTINGS AND HIGH DUTY CYCLE ON THE BATTERY VOLTAGE, AND ISN¿T INDICATIVE THAT THE BATTERY IS DEPLETING FASTER THAN EXPECTED. IN ACTUALITY, BASED ON THE DATA FROM THE LAST OFFICE VISIT IT IS MORE LIKELY THAT CLOSE TO 50% OF BATTERY CAPACITY REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926843 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 6911 05425025750061

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male