BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2990678 · Received March 5, 2013

    Report

    Report Number
    1644487-2013-00595
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY/DIAGNOSTIC HISTORY, AND DEVICE MANUFACTURING RECORDS PERFORMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO CTS ON (B)(6) 2013 THAT A VNS PATIENT HAD HIGH IMPEDANCE WITH OHM VALUE GREATER THAN 10,000 AND LOW OUTPUT CURRENT. THE LAST GOOD DIAGNOSTICS WAS ON (B)(6) 2013 HOWEVER HIGH IMPEDANCE WAS OBSERVED ON (B)(6) 2013. THE PHYSICIAN DID NOT TURN OFF THE DEVICE AFTER THE HIGH IMPEDANCE WAS OBSERVED AND NO X-RAYS WERE DONE. THE PATIENT WAS REFERRED TO A SURGEON FOR A LEAD REVISION PROCEDURE. CLINIC NOTES RECEIVED ON (B)(4) 2013 INDICATED THAT PATIENT IS NOT RECEIVING ANY THERAPY DUE TO THE HIGH LEAD IMPEDANCE. FOLLOW-UP REVEALED THAT THE PATIENT HAS ATONIC SEIZURES AND IT WAS BELIEVED THE PATIENT FELL DURING A SEIZURE WHICH RESULTED IN THE HIGH LEAD IMPEDANCE AS DIAGNOSTICS WERE OK ONE WEEK PRIOR TO THE HIGH LEAD IMPEDANCE. THE PATIENT'S LEAD AND GENERATOR WERE EXPLANTED AND REPLACED ON (B)(6) 2013 AND HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS IS CURRENTLY IN PROGRESS AND HAS NOT BEEN COMPLETED AT THIS TIME. THE DEVICE HISTORY RECORD (DHR) FOR THE LEAD AND GENERATOR WERE REVIEWED AND NO ISSUES WERE FOUND THAT WOULD HAVE RESULTED IN HIGH LEAD IMPEDANCE OR ANY FAILURE OF EITHER DEVICE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS PERFORMED ON THE EXPLANTED GENERATOR AND LEAD. ANALYSIS OF THE PULSE GENERATOR SHOWED THAT THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS, AND THAT THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. ANALYSIS OF THE LEAD ASSEMBLY IDENTIFIED A BREAK AT THE END OF THE POSITIVE AND THE NEGATIVE LEAD COILS. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOWED THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAD OCCURRED AT THE COIL END. ALSO, THE POSITIVE COIL HAD MECHANICAL DISTORTION (SMOOTHED SURFACES) AND SCRATCHES IN THE VICINITY OF THE COIL END. SCANNING ELECTRON MICROSCOPY IMAGES OF THE NEGATIVE COIL SHOWED THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAD OCCURRED AT THE COIL END. DUE TO METAL DISSOLUTION AND SURFACE CONTAMINATION, THE FRACTURE MECHANISM OF THE POSITIVE AND THE NEGATIVE COIL ENDS COULD NOT BE DETERMINED. NOTE THAT SINCE THE ELECTRODE ARRAY PORTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94135 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 011608

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR