BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 106

    MDR report key: 5806861 · Received July 19, 2016

    Report

    Report Number
    1644487-2016-01633
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    May 21, 2016
    Report Date
    May 29, 2024
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE MOTHER OF THE PATIENT THAT THE DEVICE WAS EXPLANTED. THE PRODUCT HAS NOT BEEN RECEIVED TO DATE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    THE GENERATOR DECODER WAS REVIEWED ON (B)(6) 2016 AND SHOWS THAT ON (B)(6) 2016 THE PATIENT CAME INTO THE OFFICE AT DISABLED SETTINGS WHEN THEY WERE PREVIOUSLY INTERROGATED IN (B)(6) AT SETTINGS OF 2/20/250/21/1.1/2.25/500/60 WITH AUTOSTIM 2.25/500/60. REVIEW OF THE DECODER DOES SHOW THAT THE SETTINGS WERE DISABLED ON (B)(6) 2016 DUE TO A "BURST WATCHDOG TIMEOUT" THE PHYSICIAN HAD CALLED CTS ON (B)(6) 2016 AND WAS INSTRUCTED TO PROGRAM THE MAGNET MODE GREATER THAN AUTOSTIM SO THE FINAL SETTINGS ON (B)(6) 2016 WERE 1.5/20/250/21/1.1/1.75/250/60 WITH AUTOSTIM 1.625/250/60. THE LAST RECORDED SETTINGS WERE FROM (B)(6) 2016 AND SHOW 1.75/30/250/21/1.1/2/250/60 AUTOSTIM 1.875/250/60.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2016 FROM THE PHYSICIAN THAT THE PATIENT WAS SEEN THAT DAY DUE TO INCREASE IN SEIZURES. AT THE PATIENT'S LAST APPOINTMENT IN (B)(6) THE DEVICE WAS SET TO 2.0/20/250/21/1.1, MAG 2.25/60/500, AUTOSTIM 2.25/60/500, WITH THE THRESHOLD AT 40% AND SENSITIVITY TO 1 THEN INTERROGATED IT TO CONFIRM PROGRAMMING. THE PHYSICIAN STATED THAT SHE INTERROGATED THE PATIENT'S DEVICE ON (B)(6) 2016 AND FOUND THAT ALL OUTPUT CURRENT SETTINGS (NORMAL, MAGNET, AND AUTOSTIM) HAD BEEN RESET TO 0MA AND SHE STATED THERE WAS A MESSAGE THAT SAID "THE DEVICE HAS GONE INTO PROTECTIVE MODE." SHE LOOKED AT THE MAGNET HISTORY AND THE LAST MAGNET SWIPE RECORDED WAS ON (B)(6) 2016, SO SHE THINKS THIS MAY HAVE BEEN WHEN IT HAPPENED, AND PATIENT HAS LIKELY BEEN WITHOUT THERAPY SINCE THEN. THE PHYSICIAN TURNED THE DEVICE BACK ON, BUT AT 1.5MA, 1.625 AUTOSTIM, 1.75 MAGNET. SHE WANTED AUTOSTIM TO BE HIGHER THAN NORMAL MODE, BUT DIDN'T WANT THE MAGNET TO BE A FULL 0.5 MA HIGHER. ALL OTHER SETTINGS HAD NOT BEEN CHANGED AND WERE KEPT THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460993 PULSE GEN MODEL 106 GENERATOR LYJ LIVANOVA USA, INC. 106 203698

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Other