BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3823884 · Received May 21, 2014

    Report

    Report Number
    1644487-2014-01322
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 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

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

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED CT SCANS OF IMPLANTED DEVICE. DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. CT SCANS REVIEWED BY MANUFACTURER, UNABLE TO ASSESS LEAD CONTINUITY OR LEAD PIN INSERTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT'S DEVICE WAS DISABLED ON (B)(6) 2014. X-RAYS WERE PROVIDED TO THE MANUFACTURER FOR FURTHER REVIEW. THE GENERATOR APPEARS IN THE LEFT CHEST IN A NORMAL PLACEMENT. DUE TO THE POOR QUALITY OF THE IMAGES, LEAD PIN INSERTION AND THE FILTER FEED-THROUGH WIRES CANNOT BE ASSESSED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTIC RESULTS REVEALED HIGH LEAD IMPEDANCE (DC DC - 7). THE PATIENT¿S DEVICE WAS NOT PROGRAMMED OFF FOLLOWING THE HIGH IMPEDANCE OBSERVATION. CT SCANS WERE PROVIDED TO THE MANUFACTURER FOR REVIEW BUT WERE UNABLE TO DETERMINE THE INTEGRITY OF THE LEAD AND WHETHER THE LEAD PIN WAS FULLY INSERTED INTO THE GENERATOR HEADER. THE LAST KNOWN GOOD SYSTEM DIAGNOSTIC RESULTS WERE FROM THE DATE OF IMPLANT. PATIENT MANIPULATION OR TRAUMA IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. FURTHER FOLLOW-UP REVEALED THAT THE IMPLANT SURGEON HIT THE PATIENT¿S JUGULAR AS HE TUNNELED FROM CHEST TO NECK. THE PATIENT WAS SEEN 15 DAYS AFTER IMPLANT SURGERY AND PRESENTED WITH SEVERE VOICE HOARSENESS. THE PATIENT¿S DEVICE WAS PROGRAMMED ON DURING AN OFFICE VISIT ON (B)(6) 2013. DURING THE OFFICE VISIT ON (B)(6) 2014, THE PATIENT¿S DEVICE SETTINGS WERE INCREASED. A DIAGNOSTIC TEST WAS SUBSEQUENTLY PERFORMED AND A WARNING MESSAGE APPEARED INDICATING HIGH IMPEDANCE AND LIMITED OUTPUT CURRENT. THE NEUROLOGIST MISINTERPRETED THE DIAGNOSTIC RESULTS AND INCREASED THE PATIENT¿S DEVICE SETTINGS. A SECOND DIAGNOSTIC TEST WAS PERFORMED WHICH REVEALED THE HIGH LEAD IMPEDANCE. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. NO KNOWN INTERVENTIONS HAVE OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303165 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 202521

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR