BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL UNK

    MDR report key: 3222463 · Received July 12, 2013

    Report

    Report Number
    1644487-2013-02083
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INADVERTENTLY REPORTED THE INCORRECT DATE.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. MANUFACTURER REVIEWED DEVICE HISTORY RECORDS. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. REVIEW OF LEAD DEVICE HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A VNS TREATING NURSE REPORTED THAT THE PATIENT WHO RECENTLY HAD GENERATOR REPLACEMENT ON (B)(6) 2013 WAS RECENTLY CHECKED BY THE NURSE FOR THE FIRST TIME AFTER RECEIVING NEW MEDICAL CARE. THE NURSE CHECKED THE VNS SYSTEM VIA DIAGNOSTICS PRIOR TO REPLACEMENT SURGERY AND IN RECOVERY AFTER SURGERY. ALL WAS REPORTEDLY OKAY WITH THE LEAD, ACCORDING TO THE DIAGNOSTIC READINGS. THE PATIENT WAS LATER SEEN IN THE LOCAL EMERGENCY ROOM A COUPLE OF DAYS LATER DUE TO SOME ABDOMINAL PAIN FOUND TO BE MOSTLY GAS AND NOT RELATED TO VNS. HOWEVER, A CHEST X-RAY WAS PERFORMED, AND THE VNS LEAD WAS FOUND TO BE FRACTURED AS CONFIRMED BY THE SURGEON. THE NURSE REPORTED A ¿7.5 CM GAP BETWEEN THE ENDS OF THE LEAD IN PATIENT'S CHEST.¿ THE PATIENT WAS SEEN ON (B)(6) 2013 FOR POST-OP VNS VISIT, AND SHE AGAIN CHECKED THE LEAD WITH OKAY RESULTS WITH LEAD IMPEDANCE VALUE AT 3561 OHMS. THE NURSE TURNED OFF THE DEVICE ON (B)(6) 2013, AND REPORTED THAT THE PATIENT MAY OR MAY NOT HAVE THE LEAD REPLACED. NO MANIPULATION OR TRAUMA WAS REPORTED TO THE NURSE THAT MAY HAVE CONTRIBUTED TO THE LEAD FRACTURE. THE PATIENT HAS NOT REPORTED A CHANGE IN STIMULATION PERCEPTION; HOWEVER, THE PATIENT IS DEVELOPMENTALLY DELAYED SO THE NURSE IS NOT SURE THAT HE WOULD KNOW TO REPORT IT. ATTEMPTS FOR LEAD PRODUCT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. AP CHEST AND ABDOMINAL X-RAYS WERE RECEIVED BY THE MANUFACTURER FOR REVIEW. BASED ON THE X-RAYS IMAGES RECEIVED, THERE IS A GROSS LEAD FRACTURE IN APPROXIMATELY THE MIDDLE PORTION OF THE LEAD WHICH IS MOST LIKELY A RESULT OF THE PATIENT TWIDDLING THE LEAD IN THE CHEST. ALSO, THE PORTION OF THE LEAD BEHIND THE GENERATOR COULD NOT BE ASSESSED, THEREFORE A LEAD FRACTURE IN THAT PORTION OF THE LEAD CANNOT BE RULED OUT. THE PRESENCE OF AN ADDITIONAL MICRO-FRACTURE IN THE LEAD ALSO CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324456 LEAD MODEL UNK LEAD LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR