BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2044832 · Received April 1, 2011

    Report

    Report Number
    1644487-2011-00695
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED WHEN IT WAS DISCOVERED THAT THE VNS PATIENT HAD HER VNS GENERATOR REPLACED ON (B)(6) 2011 DUE TO END OF SERVICE. A BATTERY LIFE CALCULATION WAS PERFORMED WITH THE LIMITED PROGRAMMING HISTORY AVAILABLE WHICH REVEALED 0.49 YEARS UNTIL ERI=YES. HOWEVER, THERE WERE LARGE GAPS OF YEARS MISSING IN THE PROGRAMMING HISTORY, PARTICULARLY 2006-2009 AND 2009-PRESENT. ATTEMPTS WERE MADE FOR THE RETURN OF THE EXPLANTED GENERATOR BUT THE HOSPITAL REPORTED THAT IT WAS DISCARDED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 A VNS PT CALLED THE MFR REPORTING THAT SHE WAS HAVING AN MRI DONE BECAUSE SHE HAD A BLACK-OUT EPISODE LAST WEEK, BUT COULDN'T REMEMBER THE EXACT DATE. SHE SAID THAT SHE WOKE UP AT 2 AM AND WHILE SITTING ON HER BED SHE TRIED TO FOCUS AND WALKED TO THE BATHROOM DOOR. THE NEXT THING SHE REALIZED WAS HER HUSBAND HOLDING HER AND TRYING TO HELP HER TO STAY UP. SHE SAID HER FACE WAS RED BURNED AND SHE HAD BLACK EYES. SHE WENT TO SEE THE PHYSICIAN THE NEXT DAY BUT THE PHYSICIAN COULDN'T TELL IF IT WAS SEIZURE THAT SHE HAD OR NOT. SHE HAD AN EEG DONE AND IT SHOWED ABNORMAL SEIZURE ACTIVITY. THE PT SAID THAT SHE DOESN'T FEEL STIMULATION, BUT HER VOICE STILL CHANGES PERIODICALLY ABOUT EVERY 20 MINUTES. THE PT'S PROGRAMMING HISTORY IN THE MFR'S DATABASE WAS REVIEWED AND NO ANOMALIES WERE NOTED. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED ABOUT 1.16 YEARS UNTIL ERI = YES. THE PHYSICIAN WAS CONTACTED AND THE NURSE REPORTED THAT THEY HAVE NO KNOWLEDGE OF THE PT'S BLACK-OUT EPISODE. THE PT WAS SEEN ON (B)(6) 2011 AND WAS EXPERIENCING AN INCREASE IN SEIZURES, UNK RELATIONSHIP TO PRE-VNS LEVELS, AND MIGRAINES. THE PHYSICIAN SAID AN EEG WAS DONE BECAUSE THEY DO NOT KNOW THE CAUSE OF THE OF THE INCREASE IN SEIZURES OR MIGRAINES. THE EEG SHOWED ABNORMAL RESULTS THEREFORE, THE PHYSICIAN ORDERED AN MRI TO BE DONE. THE PT HAS A HISTORY OF MIGRAINES, BUT UNK IF PRE-VNS. THE MRI WAS DONE ON (B)(6) 2011 AND ATTEMPTS FOR ADDITIONAL INFO HAVE BEEN TO NO AVAIL THUS FAR. IF ADDITIONAL INFO IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 7976

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention