BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3854175 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01413
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVE DATE (MO/DAY/YR), CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INADVERTENTLY OMITTED THE LEAD EXPLANT DATE: THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS AND AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ATTEMPTS FOR PRODUCT RETURN SHOWED THAT THE NORMAL PROTOCOL WAS THE DESTROY EXPLANTS AFTER 30 DAYS; THEREFORE, THE EXPLANTED DEVICES WERE LIKELY DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE DURING AN OFFICE VISIT ON (B)(6) 2014. THE PATIENT¿S DEVICE WAS SUBSEQUENTLY PROGRAMMED OFF. PATIENT MANIPULATION OR TRAUMA IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014. THE PATIENT¿S GENERATOR WAS REPLACED AND TESTED WITH THE EXISTING LEAD WHICH STILL SHOWED HIGH IMPEDANCE. THE SURGEON ATTEMPTED TO REPLACE THE PATIENT¿S LEAD BUT WAS UNABLE EXPLANT IT DUE TO SCAR TISSUE. THE SURGEON WAS UNABLE TO IMPLANT A NEW LEAD DUE TO THE PATIENT¿S ANATOMY. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE PATIENT¿S LEAD. THE PATIENT'S LEAD HAS NOT BEEN REPLACED TO DATE. REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY SHOWED NORMAL DIAGNOSTIC RESULTS THROUGH (B)(6) 2012.

    Description of Event or Problem · 1

    SURGERY NOTES FROM (B)(6) 2014 WERE RECEIVED INDICATING THAT THE PATIENT'S OLD ELECTRODES WERE REMOVED EXCEPT THE FEW MILLIMETERS THAT WERE LOCKED AROUND THE VAGUS NERVE. THERE WAS DENSE SCAR TISSUE BETWEEN THE VAGUS NERVE AND THE JUGULAR VEIN. WITH REPEATED ATTEMPTS AT MICROSURGICAL DISSECTION TO FREE UP AN AREA OF THE VAGUS NERVE FOR A NEW LEAD, THIS WAS UNSUCCESSFUL DUE TO THE TENACIOUS SCAR TISSUE AND THE RISK OF DAMAGING THE NERVE OR THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331260 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200382

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR