BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 1000

    MDR report key: 16068599 · Received December 29, 2022

    Report

    Report Number
    1644487-2022-01675
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    January 10, 2022
    Report Date
    April 6, 2023
    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
    PL
    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

    TABLET DATA WAS RECEIVED AND A DECODER REVIEW WAS PERFORMED. THE DEVICE WAS SEEN TO BE IN A STIM INHIBITED STATE ON TWO SEPARATE OCCASIONS CAUSING A FALSE LOW IMPEDANCE READING AS WELL AS FALSE HIGH OUTPUT MESSAGE. THIS IS DUE TO THE DEVICE NOT ABLE TO RETRIEVE AN IMPEDANCE READING WHILE IN A STIM INHIBITED STATE AND USING THE MOST RECENT STORED BURST DELIVERY AS OUTPUT READING. THE MOST LIKELY CAUSE OF THE DEVICE BEING IN A STIM INHIBITED STATE IS A REED SWITCH MALFUNCTION AS THIS EVENT MEETS LIMITED INVESTIGATION CRITERIA FOR A PREVIOUS INVESTIGATION INTO HISTORICAL DATA FOR REED SWITCH MALFUNCTIONS. EXPLANT SURGERY WAS PERFORMED AND THE DEVICE IS SCHEDULED FOR RETURN BUT HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INITIAL IMPLANTATION OF GENERATOR, PATIENT COMPLAINED FOR NECK PAIN WHICH THEY ASSOCIATED WITH VNS SYSTEM. IT WAS STATED THAT LOW IMPEDANCE WAS FOUND DURING ONE OF THE VISITS AND THE DEVICE WAS DISABLED. X-RAY EXAMINATION WAS PERFORMED AND NO DAMAGE/BREAKAGE OF THE ELECTRODE WAS OBSERVED. THE PATIENT INSISTED ON REMOVING THE GENERATOR IN WHICH SHE WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2022. DURING THE STAY IN THE HOSPITAL, THE PROPER FUNCTIONING OF THE SYSTEM WAS FOUND, SO THERAPY STARTED AGAIN. AFTER THE DEVICE WAS TURNED ON, THE PATIENT REPORTED IMPROVEMENT. IN THE NEXT VISIT, DEVICE PARAMETERS WERE INCREASED WHERE THE PATIENT REPORTED DISCOMFORT DURING STIMULATION, THEREFORE DEVICE WAS TURNED OFF AGAIN. NEXT VISIT, MULTIPLE ATTEMPTS WERE MADE TO TEST THE SYSTEM. EACH TIME THE CONNECTION WAS INTERRUPTED. OUTPUT CURRENT HIGH WAS FOUND WITH NORMAL IMPEDANCE AND OUTPUT CURRENT WAS SET TO 0.25MA YET WAS DELIVERING 0.375MA. SYSTEM WAS THEN TURNED OFF. A FEW DAYS LATER THERAPY WAS ENABLED TO 0.25MA AGAIN AND THE SAME RESULT OF OUTPUT CURRENT HIGH WAS FOUND WITH NORMAL IMPEDANCE WITH OUTPUT DELIVERING 0.375MA. THE DEVICE WAS DISABLED AND REVISION SURGERY IS CURRENTLY PLANNED. DEVICE HISTORY RECORDS WERE REVIEWED. M1000 SN (B)(4) PASSED ALL FUNCTIONAL AND QUALITY TESTING PRIOR TO DISTRIBUTION. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. PATIENT ID: (B)(6). M1000 SN (B)(4) (DOI (B)(6) 2021) ON (B)(6) 2022 SYSTEM DIAGNOSTICS SHOW OUTPUT CURRENT - HIGH, LEAD IMPEDANCE - OK 3641 OHMS, BATTERY - OK 75-100%. PARAMETERS ARE SET TO 0MA OUTPUT FOR NORMAL, AUTOSTIM, AND MAGNET MODE WITH SEIZURE DETECTION ENABLED WITH 30% AUTOSTIM THRESHOLD.

    Description of Event or Problem · 0

    THE DEVICE WAS RECEIVED INTO PRODUCT ANALYSIS WHICH IS UNDERWAY BUT NOT YET COMPLETED. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    GENERATOR PRODUCT ANALYSIS WAS APPROVED. THERE WERE NO PERFORMANCE, OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. ALTHOUGH THE REED SWITCH MALFUNCTION WAS NOT CONFIRMED BY PRODUCT ANALYSIS, THIS REMAINS THE INVESTIGATIVE CONCLUSION OF THE REPORTED EVENTS AS CONFIRMED FROM THE DECODER REVIEW AND ASSESSMENT OF HISTORICAL DATA. THE REED SWITCH LIKELY BECAME FREE PRIOR TO THE DEVICE'S RECEIPT FOR ANALYSIS RESULTING IN THE MALFUNCTION IN THE LAB. THE ROOT CAUSE OF THE EVENT IS DEVICE FAILURE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354906 PULSE GEN MODEL 1000 GENERATOR LYJ LIVANOVA USA, INC. 1000 6921 05425025750405

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention