BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 20014107 · Received August 21, 2024

    Report

    Report Number
    1644487-2024-01058
    Event Type
    Malfunction
    Date Received
    August 21, 2024
    Date of Event
    July 26, 2024
    Report Date
    October 29, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 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 LATER REPORTED THAT PATIENT WAS IN THE ER AFTER HAVE 39 SEIZURES IN 10 MINUTES AND PLANS WERE MADE FOR SURGICAL INTERVENTION. THE PATIENT LATER HAD A BATTERY REPLACEMENT. QUALITY ENGINEERING REVIEW OF THE NEW INFORMATION OBTAINED INCLUDING AN INCREASE IN PATIENT SEIZURES AND THE MAGNET NOT ELICITING A RESPONSE FROM THE GENERATOR IS FURTHER INDICATIVE OF A STUCK CLOSED REED SWITCH AS THEORIZED IN THE INITIAL QUALITY ENGINEERING REVIEW. THE EXPLANTED DEVICE HAS BEEN RECEIVED INTO PRODUCT ANALYSIS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS SEEN WITH LOW OUTPUT AND OK IMPEDANCE. PATIENT WAS RE-INTERROGATED AND SEEN WITH OK OUTPUT AND LOW IMPEDANCE. PATIENT IS REFERRED FOR XRAYS. PROGRAMMING HISTORY WAS REVIEWED CONFIRMING THAT THE DEVICE LIKELY HAS A STUCK CLOSED REED SWITCH. QUALITY ENGINEERING REVIEW WAS ALSO PERFORMED WHICH ALSO CONCLUDED THAT THE DEVICE LIKELY HAS A STUCK CLOSED REED SWITCH. DEVICE HISTORY RECORDS WERE REVIEWED AND THE GENERATOR WAS SEEN TO PASS ALL FUNCTIONAL AND QUALITY TESTING PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    THE PHYSICIAN HAS RESPONDED THAT THE SEIZURE LEVEL ROSE TO ABOVE PRE-VNS BASELINE LEVELS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    PRODUCT ANALYSIS WAS COMPLETED AND CONFIRMED A REED SWITCH STUCK CLOSED MALFUNCTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006959 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Required Intervention