BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 15395127 · Received September 9, 2022

    Report

    Report Number
    1644487-2022-01124
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 11, 2022
    Report Date
    June 22, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    00542502575003
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 "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

    IT IS SUSPECTED THAT CONDUCTIVE RESIDUES DEPOSITED ON THE EDGE OF THE CIRCUIT BOARD DURING THE LASER-ROUTING MANUFACTURING PROCESS LIKELY PROMOTED AN ENVIRONMENT CONDUCIVE FOR DENDRITIC GROWTH TO OCCUR BETWEEN TEST POINTS ON THE TELEMETRY AND RESET CIRCUITS. THE GROWTH LIKELY CREATED CURRENT PATHS THAT CAUSED UNINTENDED ELECTRICAL FUNCTION, WHICH WERE THEORIZED TO BURN OUT, GROW BACK AND CAUSE A RESET, AND BURN OUT AGAIN. THIS PROCESS EXPLAINS WHY RESETTING GENERATORS WOULD FUNCTION NORMALLY AFTER STIMULATION WAS ENABLED AND THEN ENCOUNTER A SUBSEQUENT RESET AT AN UNPREDICTABLE TIME LATER. THE PROBABLE ROOT CAUSE IS CONSIDERED RELATED TO THE LASER-ROUTING PROCESS TO A MANUFACTURING ERROR. THE MANUFACTURING PROCESS INCLUDED LASER-ROUTING WHICH CREATED AN ENVIRONMENT FOR DENDRITIC GROWTH WHICH IN TURN CAUSED THE HARDWARE RESETS. LIVANOVA SEPARATELY DISCONTINUED THE LASER-ROUTING PROCESS FOR M103, M104, M7103, AND M8103 GENERATORS ON JUNE 7, 2021.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT IS EXPERIENCING AN INCREASE IN SEIZURES AFTER HAVING DEVICE TURNED BACK ON. PATIENT HAD DEVICE INTERROGATED AND PHYSICIAN NOTED THAT THE DEVICE WAS OFF. GENERATOR DATA WAS REVIEWED AND REVEALED HARDWARE RESETS. THE PATIENT'S DEVICE IS CURRENTLY ENABLED. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    INTERNAL INVESTIGATION FOUND THE ROOT CAUSE OF THE HARDWARE RESET TO BE DUE DENDRITIC GROWTH OBSERVED ON THE ROUTED EDGE OF THE PRINTED CIRCUIT BOARD ASSEMBLY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT PATIENT HAD A BATTERY REPLACED DUE TO THE HARDWARE RESET. EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214811 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 5162 00542502575003

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Other