BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 6263714 · Received January 19, 2017

    Report

    Report Number
    1644487-2017-03056
    Event Type
    Injury
    Date Received
    January 19, 2017
    Date of Event
    July 15, 2013
    Report Date
    October 9, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION, CORRECTED DATA: DIAGNOSTICS INFORMATION WAS INADVERTENTLY NOT PROVIDED ON FOLLOW-UP REPORT #1. RELEVANT TESTS/LABORATORY DATA, CORRECTED DATA: DIAGNOSTICS RESULTS WERE INADVERTENTLY NOT PROVIDED ON FOLLOW-UP REPORT #1. DATE RECEIVED BY MANUFACTURER, CORRECTED DATA: THE DATE THE INFORMATION WAS RECEIVED WAS INADVERTENTLY PROVIDED INCORRECTLY, WHEN IT SHOULD HAVE BEEN PROVIDED AS 01/27/2017.

    Description of Event or Problem · 1

    FOLLOW-UP WAS RECEIVED FROM THE PHYSICIAN AND PROVIDED THAT THE PATIENT HAS PSYCH ISSUES DOCUMENTED IN HIS CHART AND HAS SINCE BEEN DISMISSED FROM HIS PRACTICE. HE SAID THAT HIS DEVICE WAS WORKING FINE AND THERE WERE NO ISSUES. THE PATIENT HAD AN EMU ADMISSION AND THEN ONE APPOINTMENT WITH THE PHYSICIAN AND THEN WAS DISMISSED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED LINKING THE EVENTS OF THIS REPORT TO THE PATIENT'S EXPLANT IN 2020 WHICH WAS ALREADY REPORTED IN MFR REPORT #1644487-2020-01129. PLEASE SEE MFR REPORT #1644487-2020-01129 FOR ALL FURTHER RELEVANT INFORMATION REGARDING THIS REPORT, INCLUDING PRODUCT ANALYSIS RESULTS AND ANY FUTURE INFORMATION RECEIVED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED ON 06/26/2017 THAT THE VNS NORMAL MODE STIMULATION IS NO LONGER WORKING. HE SAYS IT ONLY WORKS AS A "RESCUE DEVICE" WHEN HE SWIPES THE MAGNET, AND THAT SOMETIMES WHEN THE MAGNET IS SWIPED IT PROVIDES MINUTES OF CONTINUOUS STIMULATION AND WON'T TURN OFF AND NO LONGER ALTERS HIS VOICE. HE IS ABLE TO ABORT OR LESSEN THE SEVERITY OF HIS SEIZURES AND HIS CAREGIVERS ALSO USE THE MAGNETS AS A RESCUE. HE HAS TAPED A MAGNET OVER HIS CHEST, NEXT TO THE GENERATOR, BECAUSE HE THINKS THAT THE ONLY WAY HE WILL GET IT TO WORK IS TO HAVE THE MAGNET THERE SO HE CAN RAPIDLY MOVE IT TO ACTIVATE THE GENERATOR ON DEMAND. SETTINGS WERE TURNED UP ON (B)(6) 2017. DIAGNOSTICS WERE WITHIN NORMAL LIMITS ON (B)(6) 2017. FOLLOW-UP FROM THE PATIENT PROVIDED FURTHER THAT THE GENERATOR SETTINGS WERE TURNED UP. HE SAID HE IS ALREADY FEELING BETTER. FOLLOW-UP FROM THE PHYSICIAN PROVIDED DIAGNOSTICS ON 05/31/2017 WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    A REVIEW OF THE MANUFACTURER¿S IN-HOUSE PROGRAMMING HISTORY DATABASE SHOWED THE DEVICE DIAGNOSTICS AS-OF (B)(6) 2013 WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    A CALL WAS RECEIVED FROM A PATIENT WHO REPORTED THE DEVICE WAS ¿FAILING¿ AND ONLY WORKING INTERMITTENTLY SINCE THE DAY IT WAS IMPLANTED. HE REPORTED HIS PHYSICIAN WAS PASSING IT OFF AS OK AND WASN¿T DOING ANYTHING ABOUT IT. THE PATIENT STATED THAT HE KNEW HIS DEVICE WAS FAILING AS HE WOULD FEEL IT WORKING INTERMITTENTLY AND THEN HE WOULD FEEL IT STOP WORKING SO HE WOULD HAVE TO ¿SHOCK OR ACTUATE THE DEVICE¿ USING THE MAGNET. THE PATIENT ALSO STATED HE KNOWS IT STOPPED WORKING BECAUSE HE ¿GOES INTO SEIZURE MODE¿. HE STATED THAT HE HAD TO HAVE A CARETAKER WITH HIM 24 HOURS A DAY JUST TO ACTIVATE THE DEVICE WITH THE MAGNET BECAUSE AS SOON AS HE RELAXES THE DEVICE STOPS. THE PATIENT STATED THAT HE HAS HAD TO BE HOSPITALIZED ON AND OFF BECAUSE OF THE SEIZURES. FOLLOW-UP TO THE PHYSICIAN¿S OFFICE PROVIDED THAT THE PATIENT IS IN NEED OF NEUROPSCYH TESTING AND THAT THERE ARE NO ISSUES THAT THEY KNOW OF WITH THE VNS. HE WAS REFERRED TO THE IMPLANTING SURGEON FOR EVALUATION OF THE LEAD WIRES BUT NO SHOWED THE APPOINTMENT BECAUSE HE WAS CONVINCED THAT THE SURGEON WAS GOING TO CUT HIS HEAD OPEN. ADDITIONAL RELEVANT INFORMATION HAS NOT BEEN RECEIVED TO-DATE.

    Description of Event or Problem · 1

    FOLLOW-UP TO THE PROVIDER INDICATED THAT IMPEDANCE VALUES WERE WITHIN NORMAL LIMITS WITH THE PATIENT SITTING DOWN AS WELL AS STANDING UP. DIAGNOSTICS ON (B)(6) 2017 WERE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48624 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 3459

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization