BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 16352510 · Received February 10, 2023

    Report

    Report Number
    1644487-2023-00158
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    December 16, 2022
    Report Date
    June 16, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY DID NOT NOTE THAT THERE WAS ACCELERATED BATTERY LOSS

    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 LIVANOVAS 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

    INTERNAL DATA FROM THE GENERATOR WAS RECEIVED AND REVIEWED. THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE GENERATOR WAS EXPLANTED AND RETURNED DUE TO ACCELERATED BATTERY LOSS. PRODUCT ANALYSIS WAS COMPLETED ON THE SUSPECT GENERATOR. AN INTERROGATION (THERAPY DISABLED), (THERAPY ENABLED) A SYSTEM DIAGNOSTIC TEST, AND A WANDCOMM DIAG WERE PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS AND A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION (SHOWS A NEOS =YES CONDITION) WERE PERFORMED. THE PULSE GENERATOR WAS OPENED, THE MEASURED BATTERY VOLTAGE CONFIRMED A NEOS CONDITION. A COMPREHENSIVE AUTOMATED PCBA ELECTRICAL EVALUATION AND A BATTERY LIFE CALCULATION WERE PERFORMED. OTHER THAN THE REBOOT EVENT, NO ANOMALIES WERE SEEN, AND THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. 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 EXPLANT WHICH MAY HAVE BEEN A CONTRIBUTING FACTOR FOR THE REBOOT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED NOTING THAT THE PATIENT UNDERWENT A MASTECTOMY ON (B)(6) 2022 AND ELECTROCAUTERY MAY HAVE HIT THE GENERATOR DURING THIS SURGERY. THE EXPLANTED GENERATOR WAS RECEIVED BUT PRODUCT ANALYSIS IS STILL UNDERWAY.

    Description of Event or Problem · 0

    THE PATIENT WAS SEEN IN CLINIC AND IT WAS FOUND THAT ALL OF THEIR OUTPUT CURRENTS HAD BEEN DISABLED. THEY WERE ABLE TO PROGRAM THE DEVICE BACK ON SUCCESSFULLY. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47829 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 6789 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female