BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3884408 · Received June 19, 2014

    Report

    Report Number
    1644487-2014-01540
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    September 18, 2012
    Report Date
    August 23, 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
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY WERE REVIEWED.

    Additional Manufacturer Narrative · 1

    ADVERSE EVENT, OUTCOMES ATTRIBUTED TO ADVERSE EVENT, TYPE OF REPORTABLE EVENT; CORRECTED DATA: THE PATIENT WAS REFERRED FOR GENERATOR REVISION SURGERY WHICH IS AN INTERVENTION AND THEREFORE THE REPORT SHOULD HAVE BEEN REPORTED AS A SERIOUS INJURY NOT A MALFUNCTION.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE IS CURRENTLY ON THREE MEDICATIONS AND HAS BEEN ON TWENTY MEDICATIONS WITHIN THE PAST 15 YEARS WHICH HAVE NOT WORKED. THE PATIENT INDICATED THAT SHE HAS GOTTEN WORSE AS TIME GOES BY. SHE REPORTED THAT SHE EXPERIENCES THE SAME AMOUNT OF SEIZURES IF NOT MORE, WITH VNS THERAPY THAN SHE DID PRIOR TO VNS THERAPY. THE PATIENT REPORTED THAT FIVE OR SIX MEDICATIONS HAVE BEEN TRIED SINCE VNS IMPLANT, BUT NOTHING HAS WORKED. THE PATIENT REPORTED THAT HER PHYSICIAN HAS BEEN WORKING HARD TO DECREASE HER SEIZURES. THE PATIENT INDICATED THAT THE SEIZURES ARE ON A BI-WEEKLY BASIS AND ARE GRAND MAL SEIZURES THAT LAST APPROXIMATELY THREE TO FIVE MINUTES. THE PATIENT REPORTED THAT THE SEIZURES OCCUR USUALLY DURING OVULATION AND MENSTRUATION. THE PATIENT REPORTED THAT DEVICE SETTINGS HAVE BEEN INCREASED A FEW TIMES. THE PATIENT INDICATED THAT SHE IS OVERWEIGHT AND HAS PROBLEMS BREATHING SO THE PHYSICIAN HAS TO BE CAREFUL WITH SETTINGS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S VNS HAS NOT WORKED AS IT IS SUPPOSED TO IN TERMS OF REDUCING PATIENT¿S SEIZURES. IT WAS PREVIOUSLY DETERMINED THAT THE PATIENT IS A NON-RESPONDER TO VNS THERAPY AND THAT THE PATIENT HAS NOT RECEIVED ANY BENEFIT FROM VNS. THEREFORE THE PHYSICIAN PLANS TO ¿DISCONNECT¿ THE VNS. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT HER SEIZURES HAVE COME MORE OFTEN AND HAVE WORSENED SINCE VNS IMPLANT. FURTHER FOLLOW-UP WITH THE PHYSICIAN CONFIRMED THAT THE PATIENT IS A NON-RESPONDER AND HER SEIZURES HAVE WORSENED WITH VNS THERAPY. THE PHYSICIAN WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361673 PULSE GEN MODEL 103 GENERATOR LYJ LIVANOVA USA, INC. 103 202105

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other