BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2210436 · Received August 9, 2011

    Report

    Report Number
    1644487-2011-01817
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 12, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE PATIENT. THE PATIENT HAD THEIR GENERATOR REPLACED. THE GENERATOR HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED TO DATE. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST VIA CLINIC NOTES THAT A VNS PT WAS HAVING AN INCREASE IN COMPLEX PARTIAL SEIZURES AND HAD A GENERALIZED TONIC-CLONIC SEIZURE ON (B)(6) 2011. THE PT HAS BEEN REFERRED FOR GENERATOR REPLACEMENT SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT PRODUCT ANALYSIS HAS BEEN COMPLETED ON THE GENERATOR. RESULTS OF DIAGNOSTIC TESTING AND MONITORING INDICATED THE DEVICE WAS OPERATING PROPERLY. THE DATA IN THE (B)(6) MEMORY LOCATIONS REVEALED THAT 93.703% OF THE BATTERY HAD BEEN CONSUMED. RESULTS OF DIAGNOSTIC TESTING INDICATED THAT THE BATTERY STATUS INDICATED IFI=YES. THE BATTERY VOLTAGE VALUE STORED WITHIN THE GENERATOR (2.772 VOLTS REPORTED DURING FET) SUGGESTS THE DEVICE IS AT AN IFI CONDITION, THE BATTERY IS PARTIALLY DEPLETED. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. VISUAL INSPECTION RESULTS REVEALED NO EXTERNAL DEVICE ABNORMALITIES. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200956

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention