BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3853233 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01418
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    April 10, 2014
    Report Date
    May 7, 2014
    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 MANUFACTURING RECORDS OF THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. CORRECTED DATA: ADDITIONAL INFORMATION INDICATES THAT HIGH IMPEDANCE WAS FIRST OBSERVED ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE (>= 10,000 OHMS). X-RAYS WERE PERFORMED AND SENT TO MANUFACTURER FOR REVIEW. REVIEW OF X-RAYS DID NOT IDENTIFY ANY OBVIOUS LEAD FRACTURES; HOWEVER, THE PRESENCE OF A MICRO-FRACTURE CANNOT BE RULED OUT. THE LEAD PIN MAY NOT BE FULLY INSERTED INTO THE GENERATOR HEADER. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. NO SURGICAL INTERVENTION HAS BEEN PERFORMED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT'S DEVICE FIRST SHOWED HIGH IMPEDANCE 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 WAS REFERRED FOR SURGERY BUT NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE. X-RAYS DATED (B)(6) 2014 WERE PROVIDED TO THE MANUFACTURER FOR FURTHER REVIEW. THE GENERATOR APPEARS IN THE LEFT CHEST IN A NORMAL PLACEMENT. THE FILTER FEED-THROUGH WIRES APPEAR TO BE INTACT. THE LEAD CONNECTOR PIN COULD NOT BE CONFIRMED TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK DUE TO THE QUALITY OF THE IMAGES PROVIDED. THE ELECTRODES APPEARED TO BE PLACED IN NORMAL ARRANGEMENT. PART OF THE LEAD WAS BEHIND THE GENERATOR AND COULD NOT BE ASSESSED. NO CLEAR LEAD BREAKS OR SHARP ANGLES WERE FOUND IN THE PARTS OF THE LEAD THAT COULD BE ASSESSED. BASED ON THE IMAGES PROVIDED, THE CAUSE OF THE HIGH LEAD IMPEDANCE REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332593 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 202196

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR