BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1891001 · Received October 29, 2010

    Report

    Report Number
    1644487-2010-02429
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MANUFACTURER REVIEW OF X-RAYS OF IMPLANTED DEVICE. RESULTS: X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. CONCLUSIONS: DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    NEUROLOGY REPORTED TO OUR COUNTRY REPRESENTATIVE THAT THEY HAD A VNS PATIENT IN CLINIC WITH HIGH LEAD IMPEDANCE ON THEIR SYSTEM DIAGNOSTIC TESTING. THE PATIENT'S VNS WAS PROGRAMMED OFF. X-RAYS WERE RECEIVED FOR REVIEW AND BASED ON THE POOR IMAGE QUALITY, NO OBVIOUS ANOMALIES WERE IDENTIFIED THAT COULD BE CONTRIBUTING TO THE REPORTED HIGH LEAD IMPEDANCE. A PORTION OF THE ELECTRODE AREA WAS NOT IN THE FIELD OF VIEW, THEREFORE A LEAD DISCONTINUITY CANNOT BE RULED OUT ON THE PORTIONS OF THE LEAD UNABLE TO BE VISUALIZED. THE PIN APPEARED TO BE FULLY INSERTED BASED ON THE VIEW AVAILABLE. THE PATIENT'S LAST KNOWN GOOD SYSTEM DIAGNOSTIC TESTING WAS (B)(6) 2009 (OUTPUT STATUS OK, LEAD IMPEDANCE OK, DCDC 3). THE PATIENT HAD BECOME UNWELL WITH ACUTE SEPSIS AND SUBSEQUENT LIVER AND RENAL FAILURE IN (B)(6) 2010 AND WAS ADMITTED TO INTENSIVE CARE. THE PATIENT'S TREATING PHYSICIAN THINKS IT COULD BE POSSIBLE THE PATIENT'S VNS LEAD WAS DAMAGED WITH THE VARIOUS JUGULAR LINES THAT THE PATIENT HAD DURING HIS INTENSIVE CARE STAY. CURRENTLY THE PATIENT'S ANTIEPILEPTIC DRUG THERAPY HAS BEEN ADJUSTED AND THE PLAN IS TO REPLACE THE LEAD AND IF NECESSARY DEVICE WITHIN THE NEXT FEW MONTHS. NO SURGERY IS SCHEDULED AT THIS TIME. GOOD FAITH ATTEMPTS WILL BE MADE ONCE SURGERY IS SCHEDULED FOR THE PRODUCT TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED FROM THE AREA REPRESENTATIVE INDICATING THE PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY. SURGICAL INTERVENTION BEGAN WITH OPENING UP THE SITE OF THE DEVICE, AND ON CLOSELY EXAMINING, THE PIN WAS FULLY, CORRECTLY AND TIGHTLY INSERTED. THIS WAS CONFIRMED BY THE SURGEON AND HIS ASSISTANT. THE EXPOSED PART OF THE LEAD WAS ALSO EXAMINED, BUT THERE WAS NO DAMAGE OR ABNORMALITIES VISIBLE. THE SURGEON THEN CONNECTED A NEW GENERATOR JUST A FINAL CONFIRMATION THAT THE THERE WAS STILL A LEAD PROBLEM, AND INTERROGATION AND SYSTEM DIAGNOSTIC CHECK WAS CARRIED OUT ON THE REPLACEMENT. THE DIAGNOSTIC CHECK WAS NORMAL, WITH A DCDC OF 2. THIS WAS REPEATED SEVERAL TIMES, WITH THE SAME RESULT. THE SURGEON MANIPULATED THE AREA OF THE COILS IN THE NECK (EXTERNALLY AS NO INTERVENTION HAD TAKEN PLACED HERE) AND THE DCDC CODE REMAINED AT 2. SURGERY FINISHED WITH CLOSURE OF THE CHEST WOUND AND NO INTERVENTION REGARDING THE LEAD.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER AND UNDERWENT ANALYSIS. ANALYSIS OF THE GENERATOR INDICATED THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200793

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR