BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3414002 · Received October 16, 2013

    Report

    Report Number
    1644487-2013-03237
    Event Type
    Malfunction
    Date Received
    October 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    September 18, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH HISTORY OF CHEST PAIN RADIATING TO LEFT ARM, WITH SHORTNESS OF BREATH SINCE FOUR MONTHS. AFTER THE SIXTH TITRATION, ON (B)(6) 2013, THE PATIENT HAD LOSS OF APPETITE AND DIFFICULTY IN EATING DUE TO BURNING PAIN WHILE EATING. THE PATIENT ALSO FEELS NAUSEOUS AFTER EATING. THIS RESULTED IN LESS INTAKE OF FOOD AND LOSS OF WEIGHT AND WEAKNESS. THE PATIENT HAS LOST ABOUT 7 KG OF WEIGHT AND HAS GIDDINESS. IN VIEW OF THIS, THE AMPLITUDE AND DURATION OF THE TITRATION WERE DECREASED. THE SUBJECT IS UNDER OBSERVATION AND THE OUTCOME OF THE EVENT IS CONSIDERED NOT RESOLVED. AS PER THE OPINION OF THE PRIVATE INVESTIGATOR (BASED ON THE PATIENT NOT HAVING THESE SYMPTOMS PRIOR TO THE SIXTH TITRATION), THE EVENT IS NOT RELATED TO IMPLANTATION AND DEFINITELY RELATED TO STIMULATION. THE PATIENT WAS ADMITTED FOR INFECTION AND LOSS OF WEIGHT ON (B)(6) 2013. UPON INVESTIGATION, IT WAS DETERMINED THAT THE PATIENT HAD DENGUE FEVER, WHICH WAS NOT RELATED TO VNS. THE INFECTION WAS SIMILARLY NOT RELATED TO VNS. THE PATIENT WAS MANAGED CONSERVATIVELY AND WAS DISCHARGED ON (B)(6) 2013. ADDITIONAL INFORMATION WAS RECEIVED THAT CONCOMITANT MEDICATIONS AND HEART FAILURE COULD NOT BE A CAUSE OF THE LOSS OF APPETITE, DIFFICULTY IN EATING, NAUSEA, OR WEIGHT LOSS. THE LOSS OF APPETITE AND NAUSEA WERE NOT DUE TO PSYCHOLOGICAL REASONS. THE DIFFICULTY IN EATING DUE TO BURNING PAIN WHILE EATING IS THE CAUSE FOR THE POOR INTAKE OF FOOD. AS THE WEIGHT LOSS WAS MARKED RELATED TO STIMULATION, THE DIFFICULTY IN EATING DUE TO BURNING PAIN WHILE EATING AND FEELING NAUSEATED AFTER EATING ARE RELATED TO IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531785 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 202150

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR