BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3041379 · Received April 8, 2013

    Report

    Report Number
    1644487-2013-00950
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    July 20, 2006
    Report Date
    March 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PHYSICIAN¿S OFFICE DID NOT HAVE INFORMATION OR RECORDS FROM THE HIGH IMPEDANCE IN 2006. PRODUCT ANALYSIS WAS COMPLETED ON THE GENERATOR AND LEAD. THE GENERATOR OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. IN ADDITION, A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. NOTE THAT THE MAJORITY OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. WHAT APPEARED TO BE WHITE DEPOSITS WERE OBSERVED IN VARIOUS LOCATIONS. EDS (ENERGY DISPERSION SPECTROSCOPY ¿ PROVIDES CHEMICAL OR ELEMENT IDENTITY/COMPOSITION ANALYSIS) WAS PERFORMED AND IDENTIFIED THE DEPOSIT AS CONTAINING SILICON, PHOSPHORUS, SODIUM, SULPHUR AND CALCIUM. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. THE RESISTANCE MEASUREMENT TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PIN AT ONE POINT IN TIME. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION 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 PORTION OF THE DEVICE. NOTE THAT SINCE THE MAJORITY OF THE LEAD ASSEMBLY (BODY), INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Description of Event or Problem · 1

    IT WAS INITIALLY FOUND WHILE REVIEWING PROGRAMMING HISTORY FOR THE PATIENT THAT THE PATIENT HAD HIGH IMPEDANCE ON (B)(6) 2006. THE PATIENT HAD THEIR GENERATOR TURNED OFF (B)(6) 2007, UNKNOWN IF RELATED TO THE HIGH IMPEDANCE. THE GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143487 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 7596

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR