BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 14960348 · Received July 8, 2022

    Report

    Report Number
    1644487-2022-00826
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    June 15, 2022
    Report Date
    September 20, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750030
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTATION AN ERROR MESSAGE NOTING VBAT<EOS WAS RECEIVED. THE GENERATOR WAS INTERROGATED AND DISPLAYED FULL BATTERY AND WAS ULTIMATELY ABLE TO BE IMPLANTED. IT WAS CONFIRMED THAT THE GENERATOR WAS STORED AT ROOM TEMPERATURE. NO ADDITIONAL OR RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE REP REPORTED THAT DURING THE OPERATION, WHEN THE GENERATOR WAS ALREADY IMPLANTED AND CONNECTED TO THE LEAD, WHEN CHECKING THE IMPEDANCE, THE INDICATOR WAS VERY LOW. THIS IS THE FIRST TIME THEY FACED SUCH SITUATION. THEY RECONNECTED THE SYSTEM, INTERROGATED THE GENERATOR BUT NOTHING WORKED. ONLY AFTER ENTERING PATIENT ID (WHICH WAS NOT INITIALLY FILLED IN), GENERATOR STARTED TO WORK CORRECTLY. THE INTERNAL GENERATOR DATA WAS REVIEWED FOR THIS GENERATOR. ON THE DAY OF SURGERY, THE DEVICE WAS FOUND TO BE EOS PULSE DISABLED ALTHOUGH ONLY A SMALL PERCENTAGE OF THE BATTERY HAD BEEN CONSUMED AND THE BATTERY VOLTAGE WAS AT A VOLTAGE THAT WOULD SHOW OK BATTERY. THE TEMPERATURE AT THIS TIME WAS NOTED TO BE 22.1 C WHICH MEETS THE PRODUCT DESIGN REQUIREMENTS. IT WAS LATER REPORTED THAT THE GENERATOR WAS DELIVERED TO ST. PETERSBURG IN RUSSIA IN DECEMBER. THERE WERE NO REPORTS OF EXTREME TEMPERATURE CONDITIONS DURING DELIVERY. THE SUSPECT GENERATOR WAS THEN SHIPPED THE END OF FEBRUARY TO MOSCOW. IT WAS RECEIVED AT BEGINNING OF MARCH. ON THE DAYS OF SHIPMENT, THE AIR TEMPERATURE WAS ABOVE 0 DEGREES CELSIUS. FROM MOSCOW STOCK THE DEVICE WAS SHIPPED TO THE HOSPITAL. THE STORAGE CONDITIONS IN THE HOSPITAL IS UNKNOWN. IT IS POSSIBLE THAT THIS GENERATOR WAS EXPOSED TO COLD TEMPERATURES DURING SHIPMENT. THE LOWEST TEMPERATURE VALUE SEEN ON THE DATADUMP ONLY SHOWS THE TEMPERATURE FROM THE MOST RECENT DIAGNOSTICS. THERE IS NO WAY TO KNOW IF THE DEVICE WAS PREVIOUSLY AT A TEMPERATURE THAT WOULD TRIGGER THE EOS PULSE DISABLED STATUS. ON M103 IT ONLY TAKES A SINGLE DAILY DIAGNOSTIC BELOW THE EOS VOLTAGE TO TRIGGER THE PULSEDISABLED FLAG AND IT WILL REMAIN SET UNTIL THE DEVICE IS PROGRAMMED BACK ON BY A USER, WHICH COULD BE WHY THEY SAW THE FLAG DURING INTERROGATION BEFORE SURGERY. THE M103 WILL ALSO CONTINUE TO DO DAILY BATTERY DIAGNOSTIC REGARDLESS OF OUTPUT STATUS. IT ONLY SKIPS THE LEAD IMPEDANCE IF OUTPUT CURRENT IS PROGRAMMED TO 0MA. SO IF THIS GENERATOR WAS EXPOSED TO LOW TEMPERATURES DURING TRANSPORT, IT WOULD BE AN EXPECTED EVENT THAT THE PULSEDISABLED FLAG WOULD SHOW UPON INTERROGATION IN THE OR, BUT THE BATTERY WOULD BE BACK TO NORMAL RANGE. NO ADDITIONAL OR RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE PRODUCTS WERE DELIVERED TO ST. PETERSBURG IN RUSSIA. THE TRANSPORTATION TO THE WAREHOUSE AND ST. PETERSBURG WAREHOUSE WERE BOTH TEMPERATURE CONTROLLED. TEMPERATURE AT STORAGE AREA WITH LVN PRODUCTS DIDN'T FALL BELOW 18 DEGREES C. THE PRODUCTS WERE THEN SHIPPED TO MOSCOW. EVEN THOUGH DEVICES WERE TRANSPORTED INSIDE TERRITORY OF RUSSIA NOT IN A TEMPERATURE CONTROLLED TRANSPORT, THE DEVICES WERE KEPT WITHIN ALLOWED RANGE OF TEMPERATURES AS SPECIFIED IN LABELLING (BETWEEN -20 °C (- 4 °F) AND + 55 °C (+ 131 °F). TEMPERATURES OUTSIDE THIS RANGE CAN DAMAGE COMPONENTS). IT WAS RECEIVED. ON THE DAYS OF SHIPMENT, THE AIR TEMPERATURE WAS ABOVE 0 DEGREES CELSIUS. FROM MOSCOW STOCK THE DEVICES WERE SHIPPED TO THE HOSPITALS. EVEN THOUGH DEVICES WERE TRANSPORTED INSIDE TERRITORY OF RUSSIA NOT IN A TEMPERATURE CONTROLLED TRANSPORT, THE DEVICES WERE KEPT WITHIN ALLOWED RANGE OF TEMPERATURES AS SPECIFIED IN LABELLING (BETWEEN -20 °C (- 4 °F) AND + 55 °C (+ 131 °F). TEMPERATURES OUTSIDE THIS RANGE CAN DAMAGE COMPONENTS). THE STORAGE CONDITIONS IN THE HOSPITAL ARE UNKNOWN. IT IS POSSIBLE THAT THE GENERATORS WERE EXPOSED TO COLD TEMPERATURES DURING THE TRANSPORTS THAT WERE NOT TEMPERATURE CONTROLLED. THE AVERAGE TEMPERATURE IN FEBRUARY IN MOSCOW IS 14-25 DEGREES F, AND AVERAGE TEMPERATURE IN MARCH IN MOSCOW IS 28-41 DEGREES F. BOTH OF THESE RANGES WOULD LIKELY TRIGGER A DROP IN VOLTAGE OF THE GENERATOR BATTERY, AND THEREFORE CAUSE AN EOS MESSAGE TO BE TRIGGERED. IT IS PREVIOUSLY KNOWN THAT TEMPERATURES AS HIGH AS 50-60 DEGREES F CAN POTENTIALLY TRIGGER A TEMPORARY DROP IN BATTERY VOLTAGE. BASED ON THIS EVIDENCE, THE ROOT CAUSE OF THE PREMATURE END OF LIFE INDICATOR IS NO DEVICE FAILURE. THE LOW STORAGE TEMPERATURES DURING SHIPPING MOST LIKELY CAUSED THIS EOS INDICATOR TO APPEAR, WHICH IS A KNOWN EVENT AND NOT A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2866380 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 205742 05425025750030

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown