BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2992432 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00616
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DID NOT FEEL THE INCREASE IN SEIZURES WAS RELATED TO VNS. THERE WERE NO CAUSAL OR CONTRIBUTORY MEDICATION CHANGES, PROGRAMMING CHANGES OR OTHER EXTERNAL FACTORS THAT PRECEDED THE ONSET. THE PATIENT HAD A GENERATOR REPLACEMENT DUE TO END OF SERVICE. THE NEW GENERATOR HAD DIAGNOSTICS WITHIN NORMAL LIMITS BOTH OUTSIDE AND INSIDE THE SURGICAL POCKET. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN OPEN CAN MEASUREMENT OF THE BATTERY VOLTAGE DETERMINED THAT THE BATTERY WAS DEPLETED. THE END OF SERVICE CONDITION WAS THE RESULT OF NORMAL, EXPECTED BATTERY DEPLETION BASED ON THE BATTERY LIFE CALCULATION, THE ELECTRICAL TEST RESULTS AND THE BENCH EVALUATION. 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

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD A SEIZURE WITH STATUS EPILEPTICUS AND WAS SEEN IN THE EMERGENCY ROOM. THE PATIENT HAD A GENERATOR REPLACEMENT AND ATTEMPTS FOR PRODUCT RETURN ARE IN PROCESS. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98283 PULSE GEN MODEL 101 GENERATOR LYJ CYBERONICS, INC. 101 2702

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention