BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2810315 · Received October 31, 2012

    Report

    Report Number
    1644487-2012-02815
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 3, 2012
    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

    REPORTER INDICATED A PATIENT WAS REFERRED FOR VNS REPLACEMENT SURGERY DUE TO PROTRUSION OF THE VNS LEAD IN THE NECK AND INCREASED SEIZURES. THE LEAD PROTRUSION IS BELIEVED TO BE THE CAUSE OF THE SEIZURE INCREASE PER THE REPORTER. AN X-RAY REPORT WAS PROVIDED THAT NOTED NO ANOMALIES. ACTUAL X-RAY FILMS WERE NOT PROVIDED. ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 WHEN THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS. 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. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS OF THE CURRENT AUTOMATED FINAL TEST; THERE WERE NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION FOUND WITH THE GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013 DUE TO BATTERY DEPLETION. THE LEAD WAS TESTED AND FOUND TO BE OKAY AND WAS THEREFORE NOT REPLACED. GOOD FAITH ATTEMPTS FOR THE RETURN OF THE EXPLANTED GENERATOR WERE MADE BUT WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    ALL ATTEMPTS TO THE REPORTER FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 4309

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention