BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNS THERAPY PULSE

    MDR report key: 600888 · Received May 6, 2005

    Report

    Report Number
    1644487-2005-00294
    Event Type
    Malfunction
    Date Received
    May 6, 2005
    Date of Event
    January 1, 2005
    Report Date
    April 6, 2005
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN'S EXPERIENCED DIFFICULTY COMMUNICATING WITH THE PATIENT'S DEVICE. BOTH THE NEUROLOGIST AND THE NEUROSURGEON USED THEIR SEPARATE PROGRAMMING SYSTEMS AND NEITHER WAS ABLE TO COMMUNICTE WITH THE PATIENT'S DEVICE. IT WAS REPORTED THAT THE PATIENT WAS NOT LARGE AND THAT THE GENERATOR DID NOT SEEM TO BE PLACED TOO DEEP IN THE POCKET TO ALLOW FOR COMMUNICATION. IMPLANTING SURGEON WAS ABLE TO INTTEROGATE THE DEVICE AT THE TIME OF INITIAL IMPLANT AND DEVICE DIAGNOSTIC TESTING AT THAT TIME WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION. ELECTROMAGNETIC INTERFERENCE WAS RULED OUT AS A POTENTIAL CAUSE OF THE COMMUNICATION DIFFICULTIES. THE PATIENT UNDERWENT GENERTOR REPLACEMENT SURGERY. DEVICE DIAGNOSTIC TESTING OF THE REPLACEMENT GENERATOR CONNECTED TO THE ORIGINAL LEAD WAS WITHIN NORMAL LIMITS, INDICATING PROPER DEVICE FUNCTION AT THE TIME OF GENERATOR REPLACEMENT SURGERY. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE PULSE GENERATOR AND THE BIPOLAR LEAD REVEALED NO ANOMALIES THAT WOULD ADVERSELY AFFECT DEVICE PERFORMANCE. INVESTIGATION TO DATE HAS BEEN UNABLE TO DETERMINE THE CAUSE OF THE REPORTED COMMUNICATION DIFFICULTIES WITH THE PATIENT'S ORIGINAL GENERATOR.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT #100006-2005-16 RECEIVED FROM USER FACILITY.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS SUMMARY: THE PULSE GENERATOR DID NOT COMMUNICATE DURING BENCH TESTING. THE ANOMALY WAS NARROWED TO THE DC-DC CONVERTER IC. THE COMPONENT WAS REPLACED USING A NEW PART. THE MODULE COMMUNICATED ACCEPTABLY AFTER THE COMPONENT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS THERAPY PULSE PULSE GENERATOR LYJ CYBERONICS, INC. 102 11863

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR