BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3973702 · Received August 1, 2014

    Report

    Report Number
    1644487-2014-01917
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD WAS COMPLETED ON 08/01/2014. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE CUT END. THE MOST LIKELY CAUSE FOR THE OBSERVED PITTING CONDITION IS THAT THE GENERATOR WAS NOT PROGRAMMED OFF AT THE TIME OF EXPLANT (GENERATOR WAS STILL PROGRAMMED TO DELIVER AN OUTPUT ATTEMPTING TO DELIVER THERAPY THROUGH AN OPEN ELECTRICAL LOAD - CUT LEADS). NOTE THAT SINCE A SIGNIFICANT PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) 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. THE PHYSICIAN REPORTED THAT THE DEATH IS DOES NOT APPEAR TO BE ASSOCIATED WITH THE VNS. THERE WAS NO BELIEVED RELATIONSHIP OF THE DEATH TO VNS. THE CAUSE OF DEATH WAS REPORTED TO BE ATHEROSCLEROSIS HEART DISEASE. AN AUTOPSY WAS PERFORMED. THE PATIENT WAS FOUND UNRESPONSIVE IN BED. HEART DISEASE WAS FOUND AT THE AUTOPSY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY AND THE DEVICE WAS EXPLANTED AND READY TO BE RETURNED FOR ANALYSIS. THE CAUSE OF DEATH WAS UNKNOWN. THE GENERATOR AND LEAD WERE RETURNED FOR ANALYSIS. ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2014. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. ANALYSIS OF THE LEAD IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449914 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 014460

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death