BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3250578 · Received July 26, 2013

    Report

    Report Number
    1644487-2013-02259
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    April 1, 2012
    Report Date
    July 3, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS OBSERVED IN THE PATIENT¿S CLINIC NOTES DATED (B)(6) 2013 THAT THE PATIENT WAS EXPERIENCING A NEW AND UNUSUAL SEIZURE TYPE AND WAS REFERRED FOR A GENERATOR REPLACEMENT. THE UNUSUAL SEIZURE WAS FOLLOWED BY LEFT SIDED WEAKNESS THAT LAST 1-2 HOURS WITH FULL RECOVERY (MOST LIKELY TODD'S PARALYSIS). WORK UP INCLUDING HEAD CT, ECHO AND "CAROTID US" WERE UNREMARKABLE. SYSTEM DIAGNOSTICS WERE PERFORMED AND THE DEVICE WAS NOT AT END OF SERVICE. HOWEVER, IT IS BELIEVED THAT A WARNING MESSAGE WAS OBSERVED DURING INTERROGATION TO REPLACE THE DEVICE AS SOON AS POSSIBLE. THE PATIENT'S MEDICATION WAS INCREASED, AND NO VNS PROGRAMMING CHANGES WERE MADE. GOOD FAITH ATTEMPTS WERE MADE TO THE PHYSICIAN AND IT WAS LATER REPORTED BY THE PHYSICIAN THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES, NOT NEW AND UNUSUAL SEIZURE TYPES. THE PATIENT¿S SEIZURES IMPROVED SINCE VNS IMPLANTATION INITIALLY THEN HER SEIZURES WORSENED. THE PHYSICIAN STATED THAT THE PATIENT WAS EXPERIENCING LEFT SIDE WEAKNESS IN THEIR BODY WITH A LONGER RECOVERY TIME NEEDED AFTER THE SEIZURES TOOK PLACE. THIS EVENT WAS FIRST OBSERVED (B)(6) 2012. HE IS UNSURE AT THIS TIME IF THE INCREASE IN SEIZURE FREQUENCY IS DUE TO TODD'S PARALYSIS OR VNS THERAPY. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDED THE ONSET OF THE CHANGE IN SEIZURE TYPE. THE PATIENT HAS BEEN REFERRED FOR A GENERATOR REPLACEMENT, DUE TO THE MESSAGE NOTED ON THE HANDHELD DURING INTERROGATION STATING THAT THE DEVICE SHOULD BE REPLACED AS SOON AS POSSIBLE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT UNDERWENT GENERATOR REVISION. THE EXPLANTED GENERATOR WAS DESTROYED PER HOSPITAL PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350363 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016639

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention