BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2760755 · Received September 26, 2012

    Report

    Report Number
    1644487-2012-02441
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. DATE OF EVENT, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE DATE THAT THE HIGH IMPEDANCE WAS FIRST OBSERVED INCORRECTLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2012 THAT THE PATIENT WAS GOING TO HAVE A GENERATOR REPLACEMENT DUE TO BEING AT END OF SERVICE FOR SOME TIME. CLINIC NOTES WERE LATER RECEIVED DATED (B)(6) 2011 INDICATING THAT THEY WERE UNABLE TO COMMUNICATE WITH THE GENERATOR DUE TO A DEAD BATTERY, BUT THEY WANTED TO REPLACE THE PATIENT'S GENERATOR. THE PATIENT WAS STILL EXPERIENCING SOME SEIZURES OF ABOUT TWO TO THREE TIMES PER WEEK. THE PATIENT LATER EXPERIENCED AN INCREASE IN SEIZURES DUE TO THE DEAD BATTERY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2012 INDICATING THAT DURING GENERATOR REPLACEMENT SURGERY DUE TO END OF SERVICE, THE LEADS WERE ALSO REPLACED DUE TO HIGH IMPEDANCE THAT WAS OBSERVED DURING THE SURGERY. THE OR NURSE REPORTED THAT SHE WAS GETTING HIGH LEAD IMPEDANCE ON THE REPLACEMENT GENERATOR AFTER PERFORMING SYSTEM DIAGNOSTICS AND REINSERTING THE LEAD PIN. SHE WAS ADVISED TO PERFORM A GENERATOR DIAGNOSTIC TEST, WHICH RESULTED WITHIN NORMAL LIMITS (~3900 OHMS). SHE WAS TOLD THAT THE LEAD WILL NEED TO BE REVISED FOR THERAPY TO CONTINUE, SO SHE INFORMED THE SURGEON. NO ADDITIONAL INFORMATION WAS PROVIDED. FOLLOW UP WITH THE PATIENT'S TREATING PHYSICIAN REVEALED THAT NO X-RAYS WERE TAKEN SINCE (B)(6) 2011 BUT IT DOES NOT APPEAR THAT A COPY OF THE X-RAYS WILL BE PROVIDED TO THE MANUFACTURER FOR REVIEW. NO PROGRAMMING/DIAGNOSTIC HISTORY WAS PROVIDED BY THE PHYSICIAN SINCE IT WAS NOTED THE BATTERY WAS DEAD FOR THE PATIENT'S LAST TWO CLINIC VISITS. NO PATIENT MANIPULATION OR TRAUMA OCCURED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH LEAD IMPEDANCE. THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED BY THE MANUFACTURER; HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS FOR THE GENERATOR AND LEAD WERE COMPLETED. NOTE THAT THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS; THEREFORE, A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTIONS OF THE DEVICE WHICH MAY HAVE CONTRIBUTED TO THE STATED COMPLAINTS. THE REPORTED ALLEGATION OF FAILURE TO PROGRAM DUE TO END OF SERVICE WAS DUPLICATED IN THE PRODUCT ANALYSIS LAB AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY DEPLETION, BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 009493

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR