BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2882555 · Received December 20, 2012

    Report

    Report Number
    1644487-2012-03429
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 20, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: THE FOLLOW-UP REPORT #1 INADVERTENTLY DID NOT INCLUDE ADDITIONAL INFORMATION THAT WAS REPORTED TO THE MANUFACTURER THAT WAS RELEVANT TO THE INCREASE IN SEIZURES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR. IN THE PRODUCT ANALYSIS 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. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE GENERATOR IN THE PA LAB CONCLUDED THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE PATIENT WAS HAVING ABSENCE TYPE SEIZURES. THERE WERE NO OTHER CAUSAL OR CONTRIBUTORY CHANGES WERE NOTED WHICH PRECEDED THE SEIZURES. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT INFORMATION IS PLANNED BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURES, UNKNOWN IF ABOVE OR BELOW BASELINE. IT IS UNKNOWN OF THE INCREASE IN SEIZURES ARE RELATED TO VNS. THE PATIENT'S GENERATOR WAS REPORTED TO NOT BE AT END OF SERVICE. THE PATIENT HAD A GENERATOR REPLACEMENT AND BASED ON INFORMATION ON THE IMPLANT CARD THE GENERATOR WAS REPLACED DUE BATTERY DEPLETION WITH THE NEAR END OF SERVICE = YES. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 5423

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention