BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 16076039 · Received December 29, 2022

    Report

    Report Number
    1644487-2022-01688
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 6, 2022
    Report Date
    March 9, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING SURGERY THE NEW M106 GENERATOR WAS INTERROGATED PRIOR TO BEING OPENED AND SHOWED 75-100% BATTERY LIFE. ONCE BEING CONNECTED TO THE LEAD THE BATTERY SHOWED NEOS=YES, 0-5%. IT WAS NOTED THAT TROUBLESHOOTING WAS PERFORMED BUT THIS DID NOT RESOLVE THE ISSUE AND THAT ELECTROCAUTERY WAS REMOVED FROM THE FIELD. THE SUSPECT GENERATOR HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE SUSPECT PRODUCT WAS RECEIVED BUT PRODUCT ANALYSIS IS STILL UNDERWAY.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED GENERATOR. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE IMPLANT WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE REBOOT. AN INTERROGATION, A SYSTEM DIAGNOSTIC TEST, A VBAT CALCULATION, AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWS AN IFI=NO CONDITION) WERE PERFORMED. NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. INITIAL DATA DOWNLOAD SHOWS ¿DIAGVBAT_MIN¿ SET TO A VALUE THAT REPRESENTS A VBAT & #:60; EOS ON (B)(6) 2022, PRESUMED IMPLANT DATE WAS ON (B)(6) 2022. OTHER THAN THE NOTED EVENT (DIAGVBAT_MIN), THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2766716 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male