BEUDAMED
    FDA Adverse Event Death Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4167646 · Received October 13, 2014

    Report

    Report Number
    1644487-2014-02675
    Event Type
    Death
    Date Received
    October 13, 2014
    Date of Event
    June 24, 2014
    Report Date
    September 17, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON 10/17/2014. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. ANALYSIS OF THE LEAD WAS COMPLETED ON 10/23/2014. NOTE THAT SINCE A 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 TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION.

    Description of Event or Problem · 1

    AN EXPLANTED GENERATOR AND LEAD WERE RECEIVED FOR ANALYSIS FROM ANOTHER MEDICAL DEVICE MANUFACTURER. THE DEVICES HAD BEEN INADVERTENTLY RETURNED TO THE WRONG MANUFACTURER. IT WAS NOTED THAT THE VNS PATIENT HAD PASSED AWAY FROM NATURAL CAUSES SECONDARY TO COMPLICATIONS OF CHOLECYSTECTOMY SURGERY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE. ANALYSIS OF THE DEVICES ARE UNDERWAY, BUT HAVE NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647570 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 013755

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death