BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2923133 · Received January 18, 2013

    Report

    Report Number
    1644487-2013-00194
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    April 26, 2006
    Report Date
    December 21, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF X-RAYS BY THE MANUFACTURER REVEALED A GROSS LEAD DISCONTINUITY. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ALL ATTEMPTS TO THE REPORTER FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER. THE GENERATOR IS VISIBLE IN THE LEFT CHEST AND IS PLACED NORMALLY. THE CONNECTOR PINS ARE FULLY INSERTED INSIDE THE CONNECTOR BLOCK. THE FEEDTHRU WIRES APPEAR TO BE INTACT. THE POSITIVE ELECTRODE IS THE ONLY FULL ELECTRODE VISUALIZED DUE TO THE IMAGE CUTTING OFF AT THIS POINT. A PARTIAL VIEW OF THE NEGATIVE ELECTRODE IS SEEN; THE ELECTRODES APPEAR TO BE IN ALIGNMENT. A FRANK LEAD BREAK IS SEEN AT THE BIFURCATION ON BOTH LEAD WIRES. A STRAIN RELIEF BEND AN LOOP ARE PRESENT AND APPEAR TO BE SECURED PER LABELING WITH THREE TIE-DOWNS. THERE IS NO EVIDENCE OF LEAD KINKING OR TWISTING. THE LEAD WIRES ARE INTACT AT THE LEAD PINS. THERE IS A PORTION OF THE LEAD BEHIND THE GENERATOR; THEREFORE, THIS PORTION OF LEAD CANNOT BE ASSESSED FOR CONTINUITY. BASED ON THE X-RAYS IMAGES RECEIVED, THERE IS A GROSS LEAD FRACTURE AT THE LEAD BIFURCATION INVOLVING BOTH WIRES. 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. SURGERY TO REPLACE THE VNS LEAD AND GENERATOR IS NOT PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT HAD 4 LEAD FRACTURES NOTED VIA X-RAY FOR THE PATIENT'S LEAD. THE PATIENT HAD HIGH IMPEDANCE WITH VNS SYSTEMS DIAGNOSTICS SINCE (B)(6) 2012, AND THE PATIENT'S VNS GENERATOR IS CURRENTLY AT END OF SERVICE. THE PATIENT IS NOT HAVING ANY ADVERSE EVENTS. THE LAST ACCEPTABLE VNS DIAGNOSTICS RESULTS WERE IN (B)(6) 2012, AND THE GENERATOR WAS NOT AT END OF SERVICE AT THAT TIME. THE REPORTER WAS ADVISED TO DISABLE THE VNS, BUT IT HAS NOT BEEN CONFIRMED IF THIS HAS OCCURRED. THE PATIENT DOES MANIPULATE THE VNS AND PULL AT THE GENERATOR. THERE ARE CURRENTLY NO SURGERY PLANS FOR THE PATIENT. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28273 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 300-20 5985

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR