BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 15375019 · Received September 7, 2022

    Report

    Report Number
    1644487-2022-01103
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    December 31, 2021
    Report Date
    September 15, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    H3 OTHER TEXT : 2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-OP INTERROGATION FOR A GENERATOR REPLACEMENT, THE DEVICE SHOWED ERROR CODE 6/ DISABLED BUT THAT BATTERY WAS NOT DEPLETED AS IT IS STILL 25%. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR. THE GENERATOR PASSED ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. THE GENERATOR WAS HP STERILIZED. THE PART NUMBER FOR THE GENERATOR IS 10-0011-6102, INDICATING THIS GENERATOR CONTAINS THE OLD FIRMWARE VERSION AND THEREFORE, DOES NOT CONTAIN THE GC5 UPDATED FIRMWARE. THIS PRODUCT WAS ALSO SCREENED FOR GC5 DEFECT AND DID PASS SCREENING. ALTHOUGH THIS DEVICE DID PASS THE SCREENING, THE ERROR CODE 6 IS INDICATIVE OF A GC5 DEFECT. THE SUSPECT PRODUCT HAS NOT BEEN RECEIVED INTO PRODUCT ANALYSIS TO DATE. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS (PA) FOR THE SUSPECT GENERATOR WAS COMPLETED. VISUAL OBSERVATIONS WERE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE IMPLANT/EXPLANT PROCEDURES. LIVANOVA PREVIOUSLY IMPLEMENTED A MANUFACTURING SCREEN TO DISTRIBUTE DEVICES NOT SUSCEPTIBLE TO THE ISSUE, DISTRIBUTING THOSE DEVICES FROM THE MANUFACTURING SITE STARTING JULY 31, 2019 (P970003/S230). THE MANUFACTURING SCREEN WAS EFFECTIVE AT REDUCING THE NUMBER OF OCCURRENCES OF THE DEVICE RESET, AS INTENDED. GC5 SCREENING TESTS (PRE RESET), AN INTERROGATION, AND A SYSTEM DIAGNOSTIC TEST WERE PERFORMED. GC5 SCREENING TESTS WERE PERFORMED AT VARIOUS TEMPERATURES. THE PULSE GENERATOR PASSED ALL GC5 SCREENING TESTS. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS. THE HARDWARE RESET COULD NOT REPRODUCED. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION WAS PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. INTERNAL DATA DOWNLOAD SHOWS A REBOOT REASON OF 6. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. THE ROOT CAUSE OF THE ISSUE IS A HARDWARE BUG (E.G. ¿GC5¿ FALSE FRAM DETECTION ERROR) WITHIN THE DEVICE¿S SUPPLIED MICROCONTROLLER. THE HARDWARE BUG WAS EXACERBATED BY THE FIRMWARE CHANGES SUBMITTED IN P970003/S218. AN AMENDMENT (SUPPLEMENT S221-A001) WAS SUBMITTED IN RESPONSE TO THE PUBLICATION OF A COMPONENT ERRATA SHEET ASSOCIATED WITH THE MICROCONTROLLER WHERE THE ¿GC5¿ ERRATA WAS DISCLOSED, WHEREBY LIVANOVA IMPLEMENTED THE ¿WORKAROUNDS¿ RECOMMENDED BY THE MANUFACTURER OF THIS COMPONENT FOR THE ¿GC5¿ ITEM.

    Description of Event or Problem · 0

    GENERATOR DATA WAS REVIEWED. THE DATE OF GENERATOR RESET WAS NOW KNOWN. THE GENERATOR HAS BEEN RECEIVED INTO PRODUCT ANALYSIS. PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INTERNAL INVESTIGATION IDENTIFIED THAT THIS RESET IS NOT RELATED TO THE GC5 HARDWARE BUG. FOR THE EVENT, THE EXACT ROOT CAUSE WAS NOT DETERMINED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261616 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205161 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female