BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3081424 · Received April 26, 2013

    Report

    Report Number
    1644487-2013-01185
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    REVIEW OF PROGRAMMING HISTORY. DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE EXPLANTED LEAD AND GENERATOR WERE RETURNED ON (B)(4) 2013 FOR ANALYSIS. PRODUCT ANALYSIS ON THE GENERATOR SHOWED THAT THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE PRODUCT ANALYSIS THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR. AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTION AND THE REPORTED LEAD BREAK ALLEGATION WAS CONFIRMED. NOTE THAT THE ELECTRODES WERE NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS THE POSITIVE CONNECTOR RING QUADFILAR COIL APPEARED TO BE BROKEN APPROXIMATELY 11 MM FROM THE ELECTRODE BIFURCATION. SCANNING ELECTRON MICROSCOPY WAS PERFORMED AND IDENTIFIED THE AREA AS HAVING EXTENSIVE PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. PITTING WAS OBSERVED ON THE COIL SURFACE. IT IS BELIEVED THAT STIMULATION WAS PRESENT FOR A CERTAIN PERIOD OF TIME AS EVIDENCED BY THE PRESENCE OF METAL PITTING. WHAT APPEARED TO BE WHITE DEPOSITS WERE OBSERVED IN VARIOUS LOCATIONS. ENERGY DISPERSION SPECTROSCOPY WAS PERFORMED AND IDENTIFIED THE DEPOSIT AS CONTAINING SILICON, PHOSPHORUS, SODIUM AND CALCIUM. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITY, THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED. 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 PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2103, A SURGERY REFERRAL FORM WAS RECEIVED INDICATING THAT THIS VNS PATIENT WAS REFERRED FOR SURGERY DUE TO HIGH IMPEDANCE. DIAGNOSTICS FROM (B)(6) 2013 WERE PROVIDED. CLINIC NOTES DATED (B)(6) 2013 WERE RECEIVED. THESE INDICATED THAT THE PATIENT CONTINUED HAVE TO SEIZURE ON TO THREE TIMES WEEK THAT TENDED TO CLUSTER, LASTING ANYWHERE FROM 10-15 MINUTES. THE FATHER DID NOT BELIEVED THAT THE VNS WAS WORKING GIVEN THE CONTINUED SEIZURES. AN INTERROGATION SHOWED THAT THE SETTINGS WERE STABLE AND THAT THE CIRCUIT WAS INTACT. THE FATHER EXPRESSED CONCERNS THAT THERE WAS A BREAK IN THE LEADS, BUT THIS WAS NOT INDICATED. THE DEVICE DID INDICATE THAT THE DEVICE WAS NEAR END OF BATTERY LIFE. (THIS WAS NOT REFLECTED IN PROGRAMMING HISTORY.) FOLLOW-UP SHOWED THAT HIGH IMPEDANCE WAS FIRST SEEN ON (B)(6) 2013. THE DEVICE WAS NOT PROGRAMMED OFF AFTER HIGH IMPEDANCE WAS SEEN, NO X-RAYS WERE TAKEN, AND NO PATIENT MANIPULATION OR TRAUMA OCCUR THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PROGRAMMING AND DIAGNOSTIC HISTORY WERE PROVIDED: DIAGNOSTICS WERE WITHIN NORMAL LIMITS. THE PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013. THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182869 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 6182

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR