BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 15363159 · Received September 6, 2022

    Report

    Report Number
    1644487-2022-01104
    Event Type
    Malfunction
    Date Received
    September 6, 2022
    Date of Event
    December 23, 2021
    Report Date
    December 27, 2022
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750405
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    PATIENT WAS INITIALLY SEEN IN CLINIC AND THEIR SETTINGS COULD NOT BE ADJUSTED DUE TO RECEIVING ERROR CODE 128, COMMUNICATION ERROR. IT WAS THEN NOTED THAT THE PATIENT WAS SEEN RECENTLY AND THEIR DEVICE WAS ABLE TO BE INTERROGATED BUT WHEN TRYING TO PERFORM A SYSTEM DIAGNOSTICS, AN ERROR CODE WAS RECEIVED. TROUBLESHOOTING WAS TRIED BUT THE SAME ERROR CODE WAS RECEIVED. THE DEVICE HISTORY RECORDS OF THE GENERATOR WERE REVIEWED. THE GENERATOR PASSED FINAL QUALITY AND FUNCTIONAL SPECIFICATIONS PRIOR TO RELEASE. INTERNAL DATA FROM THE GENERATOR WAS RECEIVED AND REVIEWED, WHICH REVEALED A REED SWITCH MALFUNCTION. INTERNAL INVESTIGATION INTO CONFIRMED CASES WAS 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

    PATIENT UNDERWENT FULL REVISION SURGERY. THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED BY PRODUCT ANALYSIS TO DATE.

    Description of Event or Problem · 0

    THE PATIENT WAS SEEN BACK IN CLINIC AND A GENERATOR RESET WAS TRIED AND RESULTED IN LOW IMPEDANCE, WHICH IS EXPECTED WITH A REED SWITCH MALFUNCTION. NO KNOWN SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2809022 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 204771 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female