BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 19209601 · Received April 29, 2024

    Report

    Report Number
    1644487-2024-00495
    Event Type
    Malfunction
    Date Received
    April 29, 2024
    Date of Event
    April 4, 2024
    Report Date
    June 27, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    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

    THE PATIENT'S DEVICE WAS CHECKED AND WAS FOUND TO HAVE LOW OUTPUT CURRENT AND THE LEAD IMPEDANCE VALUE WAS WITHIN NORMAL LIMITS. IT WAS ALSO NOTED THAT ONLY AN INTERROGATION COULD BE PERFORMED BUT NOT A SYSTEM DIAGNOSTICS TEST. THE PATIENT ALSO REPORTED EXPERIENCING INCREASED SEIZURES. DEVICE HISTORY RECORDS REVIEW FOR THE M1000 GENERATOR PERFORMED. THE GENERATOR PASSED FINAL FUNCTIONAL AND QUALITY SPECIFICATIONS PRIOR TO RELEASE FOR DISTRIBUTION. INTERNAL DATA FROM THE GENERATOR WAS RECEIVED AND REVIEWED. INTERNAL INVESTIGATION INTO CONFIRMED CASES WERE UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE OF REED SWITCH FAILURES. THE PRIMARY ROOT CAUSE IS BELIEVED TO BE REED SWITCHES STICKING IN THE CLOSED POSITION AFTER EXTENDED EXPOSURE TO MAGNETIC FIELDS. THE INVESTIGATION ALSO IDENTIFIED RESIDUAL MAGNETIC PROPERTIES OF THE GENERATOR BATTERY TO BE A POTENTIAL CONTRIBUTOR; HOWEVER, TESTING PERFORMED DURING THE INVESTIGATION FOUND THE EFFECT TO BE HIGHLY VARIABLE WITH EACH MAGNETIC FIELD EXPOSURE AND ANY CLOSURE OF THE REED SWITCH IMPACTED BY THIS PHENOMENON WOULD LIKELY BE REVERSED BY SUBSEQUENT SWIPING OF THE PATIENT MAGNET. THUS, THE MOST LIKELY CONTRIBUTOR OF THE IDENTIFIED COMPLAINTS IS CONSIDERED TO BE MECHANICAL STICKING OF THE REED SWITCH BLADES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING THAT IT IS DIFFICULT TO SAY IF THE INCREASE IN SEIZURES ARE ABOVE, BELOW OR THE SAME AS PRE-VNS DUE TO POOR RECORD KEEPING. THE PATIENT IS CURRENTLY UNWELL AND HAS HAD A SIGNIFICANT PERIOD OF BEING IN THE HOSPITAL. THERE WAS NOTHING UNUSUAL THAT OCCURRED FOR THE PATIENT IN (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419902 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 205732 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization