BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2944969 · Received February 6, 2013

    Report

    Report Number
    1644487-2013-00300
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    October 3, 2008
    Report Date
    January 10, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT'S VNS GENERATOR AND LEAD WERE TO BE REPLACED AS HE FELT THERE MAY BE A MALFUNCTION OCCURRING WITH THE GENERATOR, AS THE PATIENT HAD NOT BEEN ABLE TO ACHIEVE THE SAME LEVEL OF EFFICACY AS THE PREVIOUS VNS GENERATOR AND WAS HAVING INCREASED SEIZURES. THE PATIENT WAS ALSO EXPERIENCING PAIN IN HIS NECK. FOLLOW UP WITH THE REPORTER REVEALED VNS DIAGNOSTICS WERE WITHIN NORMAL LIMITS, INDICATING PROPER FUNCTION. THE REPORTER FELT A LEAD ISSUE MAY BE OCCURRING THAT WAS CAUSING THE INCREASE IN SEIZURES AND NECK PAIN. THE CAUSE OF THE NECK PAIN IS UNCLEAR, AS THE PATIENT WAS GRABBING AT HIS NECK CAUSING SELF-TRAUMA AND THIS MAY BE WHAT THE PAIN WAS DUE TO, OR IT MAY BE THE VNS STIMULATION. IT IS UNKNOWN AS THE PATIENT IS NONVERBAL. IT WAS FELT THE INCREASED SEIZURES MAY BE CAUSED BY A DEVICE MALFUNCTION OR THE PATIENT'S OTHER COMORBIDITIES. IT IS NOT KNOWN IF MORE THAN ONE SEIZURE TYPE WAS INCREASED, OR THE LEVEL OF THE INCREASE, OTHER THAN THEY WERE INCREASED. THERE WERE NO PRECIPITATING EVENTS. THE PATIENT HAD VNS LEAD AND GENERATOR REPLACEMENT SURGERY PERFORMED ON (B)(6) 2012. THE EXPLANTED DEVICES WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Description of Event or Problem · 1

    REPORTER INDICATED VIA THE OPERATIVE NOTE RECEIVED TO THE MANUFACTURER THAT THE VNS LEAD WAS NOT REPLACED DURING THE (B)(6) 2013 SURGERY AS WAS ORIGINALLY REPORTED; ONLY THE GENERATOR WAS REPLACED. THE LEAD WAS NOT REPLACED AS VNS SYSTEMS DIAGNOSTICS PERFORMED DURING THE SURGERY WERE OK WITH 5 TESTS WITH THE NEW VNS GENERATOR AND RESIDENT LEAD. THERE WAS FELT TO BE A "POSSIBLE ABNORMALITY" OF THE LEAD PRIOR TO THE SURGERY PER THE NOTE.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S SEIZURES AND NECK PAIN HAVE IMPROVED SINCE THE VNS LEAD AND GENERATOR WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49617 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 200905

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention