BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1062981 · Received June 18, 2008

    Report

    Report Number
    1644487-2008-01410
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE LEAD AND GENERATOR WERE EXPLANTED AND THE GENERATOR WAS RETURNED TO MANUFACTURER FOR ANALYSIS. THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF SUPPLEMENTAL MFR. REPORT #1. CORRECTED DATA: THIS INFORMATION WAS INADVERTENTLY LEFT OFF OF SUPPLEMENTAL MFR. REPORT #1.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT PT RECEIVED HIGH LEAD IMPEDANCE ON SYSTEM DIAGNOSTICS. CHEST AND NECK X-RAYS WERE REVIEWED BY PHYSICIAN. NO OBVIOUS LEAD BREAKS WERE FOUND. PT WILL HAVE REVISION SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INCREASE IN SEIZURES IN (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY WHERE A NEW VNS SYSTEM WAS PLACED ON THE RIGHT SIDE. THE REVISION SURGERY WAS PREVIOUSLY REPORTED IN MFR. REPORT # 1644487-2009-00566. IT WAS REPORTED THAT THE RIGHT SIDED VNS WAS NOT AS EFFECTIVE AS THE LEFT SYSTEM PREVIOUS HAD BEEN SO THE PHYSICIAN HAS AGREED TO EXPLANT THE LEFT VNS SYSTEM AND IMPLANT A NEW SYSTEM ON THE LEFT SIDE. SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE UNDERWENT GENERATOR AND LEAD REPLACEMENT ON (B)(6) 2013. IT WAS REPORTED THAT ONLY THE LEAD IMPLANTED ON THE RIGHT VAGUS NERVE REMAINS IMPLANTED AND THAT THE LEFT VAGUS NERVE SYSTEM WAS REPLACED. ONLY THE GENERATOR FROM THE LEFT SYSTEM WAS RETURNED FOR ANALYSIS ON 09/25/2013. ANALYSIS OF THE GENERATOR WAS COMPLETED ON 10/15/2013. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE, WHICH INDICATED THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTRO-CAUTERY TOOL DURING DEVICE EXPLANT. A RESET OF THE PULSE DISABLE BIT IN THE GENERATOR MEMORY WAS PERFORMED TO ALLOW FOR AN OUTPUT TO ONCE AGAIN BE PROVIDED BY THE GENERATOR FOR SUBSEQUENT TESTING. 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. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. OTHER THAN THE NOTED CONDITION, THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1265

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR