BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 16352294 · Received February 10, 2023

    Report

    Report Number
    1644487-2023-00155
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    November 30, 2022
    Report Date
    April 17, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    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.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS (PA) WAS COMPLETED FOR THE SUSPECT GENERATOR. THE REPORTED GENERATOR RESET AND DEVICE FAILURE WERE ALL CONFIRMED IN THE PA LAB. VISUAL OBSERVATIONS ARE MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE IMPLANT/EXPLANT PROCEDURES. AN INTERROGATION AND SYSTEM DIAGNOSTIC TESTS WERE PERFORMED. THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION WAS PERFORMED. THE PULSE GENERATOR WAS OPENED, THE MEASURED BATTERY VOLTAGE CONFIRMED THE BATTERY WAS NOT DEPLETED. A COMPREHENSIVE AUTOMATED PCBA ELECTRICAL EVALUATION WAS PERFORMED. OTHER THAN THE REED SWITCH STUCK CLOSED CONDITION DURING THE 24-HOUR OUTPUT SIGNAL MONITORING PERIOD, THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THIS MDR HOUSES THE REPORT OF UNINTENTIONAL RESET ON THE PATIENT'S GENERATOR. MFR REF #1644487-2022-00977 HOUSES THE REPORT OF UNRELATED REED SWITCH MALFUNCTION ON THE PATIENT'S GENERATOR.

    Description of Event or Problem · 0

    IT WAS LATER REPORTED THAT THE SUSPECT DEVICE WAS RECEIVED INTO PRODUCT ANALYSIS. ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A RESET SEEN ON THEIR GENERATOR IN CLINIC. THE GENERATOR DATA WAS SENT IN AND REVIEWED FOR THE KNOWN REED SWITCH MALFUNCTION, BUT UPON REVIEW, AN UNEXPECTED RESET ERROR CODE 6 WAS ALSO FOUND. PATIENT LATER HAD REPLACEMENT SURGERY DUE TO THE MALFUNCTIONS. ALTHOUGH THIS DEVICE ALSO HAS EXPERIENCED A STUCK CLOSED REED SWITCH, AT THIS TIME THIS IS BELIEVED TO BE COINCIDENTAL AS OTHER DEVICES HAVE HAD THIS SAME RESET SIGNATURE WITHOUT KNOWN STUCK CLOSED REED SWITCH ISSUES. THIS MDR HOUSES THE REPORT OF UNINTENTIONAL RESET ON THE PATIENT'S GENERATOR. MFR REF #1644487-2022-00977 HOUSES THE REPORT OF UNRELATED REED SWITCH MALFUNCTION ON THE PATIENT'S GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58118 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 204897 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Female