BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3240269 · Received July 22, 2013

    Report

    Report Number
    1644487-2013-02205
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    May 1, 2013
    Report Date
    June 24, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PHYSICIAN DID NOT BELIEVE THAT THE SEIZURES ARE RELATED TO VNS THERAPY, BUT INDICATED THAT THE CAUSE IS UNKNOWN. THE PHYSICIAN REPORTED THAT IT IS UNKNOWN IF THE INCREASE IN SEIZURES IS ABOVE THE PATIENT'S PRE-VNS BASELINE, BUT THAT THE INCREASE IS SIGNIFICANT. THE PATIENT UNDERWENT PROPHYLACTIC GENERATOR REPLACEMENT ON (B)(6) 2013. IT IS UNKNOWN IF THE GENERATOR WILL BE RETURNED TO MANUFACTURER FOR ANALYSIS AS THE GENERATOR HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURES. THE BREAKTHROUGH SEIZURES CONSISTED OF STARING WITH LIP-SMACKING AND UNRESPONSIVENESS. THEY BEGAN BY OCCURRING IN CLUSTERS OVER THE FIRST WEEK AND THEN BECAME DAILY EVENTS. A CT OF THE BRAIN SHOWED NO ACUTE PROCESS. THE PHYSICIAN DID NOT SEE A CLEAR REASON FOR THE DETERIORATION OF THE SEIZURES. THE PATIENT WAS REFERRED FOR A PROPHYLACTIC GENERATOR REPLACEMENT. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2013. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Description of Event or Problem · 1

    THE GENERATOR WAS RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS ON (B)(4) 2013. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339667 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200670

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention