BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3180847 · Received June 20, 2013

    Report

    Report Number
    1644487-2013-01866
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    December 18, 2012
    Report Date
    May 27, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    ANALYSIS OF PROGRAMMING HISTORY RELEVANT DATA, CORRECTED DATA: PREVIOUSLY SUBMITTED MDR INADVERTENTLY OMITTED THE PATIENT¿S SETTINGS AT THE TIME OF THE HIGH IMPEDANCE DIAGNOSTIC. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS WERE REVIEWED BY THE MANUFACTURER. NO GROSS LEAD DISCONTINUITIES WERE VISUALIZED.

    Description of Event or Problem · 1

    MANUFACTURER REVIEW OF A PATIENT¿S VNS PROGRAMMING HISTORY IDENTIFIED THAT HIGH LEAD IMPEDANCE WAS FIRST NOTED WITH DIAGNOSTICS TESTING ON (B)(6) 2012. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2013 AND THE PHYSICIAN CONFIRMED THE HIGH IMPEDANCE. SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    A BATTERY LIFE CALCULATION SHOWS 4.70 YEARS REMAINING.

    Description of Event or Problem · 1

    THE PHYSICIAN INDICATED THAT THE PATIENT WOULD BE SEEN FOR CONSULT, BUT ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN AGAIN ON (B)(6) 2013. THE PHYSICIAN ORGANIZED AN X-RAY AND EMG MEASUREMENT. THERE WAS NOTHING UNUSUAL SEEN ON THE X-RAYS, BUT THE EMG MEASUREMENT SHOWED THE CHARACTERISTIC OF A BROKEN LEAD. VNS REVISION SURGERY WAS PERFORMED ON (B)(6) 2013. THE LEAD AND GENERATOR WERE EXPLANTED, BUT A PORTION OF THE LEAD WAS LEFT AT THE VAGUS NERVE. THE EXPLANTED DEVICE WAS LOST IN THE CLINIC, SO IT IS NOT AVAILABLE FOR RETURN. THE PATIENT WAS NOT IMPLANTED WITH A NEW VNS SYSTEM ON THIS DATE. X-RAYS WERE SENT TO THE MANUFACTURER AND REVIEWED. THE GENERATOR APPEARS IN THE UPPER LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEARED TO BE INTACT. THE LEAD CONNECTOR PIN APPEARED TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ARRANGEMENT OF THE ELECTRODES ON THE VAGUS NERVE APPEARED TO BE NORMAL. A STRAIN-RELIEF BEND WAS PRESENT, BUT NO LOOP WAS MADE, THEREFORE THE STRAIN RELIEF WAS NOT PER THE MANUFACTURER'S LABELING. ONLY ONE TIE-DOWN WAS USED BUT NOT AS INDICATED IN THE LABELING. PART OF THE LEAD WAS BEHIND THE GENERATOR. NO CLEAR SHARP ANGLES OR LEAD BREAKS WERE FOUND. BASED ON THE ASSESSED IMAGES ALONE, NO OBVIOUS CAUSE FOR THIS HIGH IMPEDANCE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DECIDED TO NOT UNDERGO VNS REIMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279615 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200822

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR