BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3121549 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01480
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 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 MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE VNS LEAD AND GENERATOR CONFIRMED BOTH DEVICES MET ALL FINAL TESTING REQUIREMENTS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT IS ¿DOING VERY WELL WITH VNS, AND IS ALMOST SEIZURE-FREE¿.

    Description of Event or Problem · 1

    MANUFACTURER REVIEW OF THE LEAD AND GENERATOR DEVICE HISTORY RECORDS CONFIRMED THE VNS LEAD AND GENERATOR MET ALL FINAL TESTING REQUIREMENTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT POST-OPERATIVE HIGH IMPEDANCE WAS SEEN WHEN A PATIENT RETURNED FOR DOSING ON (B)(6) 2013. X-RAYS WERE 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 WAS FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. A SUSPECT AREA WAS IDENTIFIED, LIKELY A SHARP ANGLE, BUT COULD NOT BE CONFIRMED BECAUSE OF LACK OF FRONTAL NECK VIEW. NO CLEAR LEAD FRACTURE WAS FOUND ON THE ASSESSABLE PORTIONS OF THE LEAD. PART OF THE LEAD WAS BEHIND THE GENERATOR. PHYSICIAN REVIEW OF THE X-RAYS SHOWED THE BATTERY TO BE RATHER LOW IN THE CHEST AREA, WHICH IS NOT WHERE IT WAS IMPLANTED, PER THE SURGEON. THE SURGEON STATED THAT IT APPEARED THAT THE BATTERY WAS DISLOCATED, AND AS A CONSEQUENCE, THE LEAD MAY BE STRAINED OR MAY HAVE COME LOOSE ON EITHER END. FOLLOW-UP SHOWED THAT THE GENERATOR WAS NOT PROGRAMMED PRIOR TO THIS. THE DEVICE WAS PROGRAMED ON, AND AFTER A CHECK, THE HIGH IMPEDANCE WARNING APPEARED. AFTER A RE-CHECK, THE DEVICE WAS PROGRAMMED OFF. THERE WAS NO KNOWN TRAUMA. THE PATIENT WAS SEEN AGAIN ON (B)(6) 2013, AND NO HIGH IMPEDANCE WAS SEEN. THE BATTERY WAS ALSO NICELY IN PLACE AND NOT DISLOCATED. THE PHYSICIAN BELIEVED X-RAY WAS POSSIBLY SHOT FROM SUPERIORLY GIVING THE IMPRESSION DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224127 LEAD MODEL 304 LEAD LYJ CYBERONICS INC 304-20 202021

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR