BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4402333 · Received January 9, 2015

    Report

    Report Number
    1644487-2015-03578
    Event Type
    Injury
    Date Received
    January 9, 2015
    Date of Event
    October 30, 2006
    Report Date
    December 10, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MEDICAL PROFESSIONAL THAT THE PATIENT¿S GI ISSUES WERE FIRST OBSERVED SINCE THE VNS WAS PROGRAMMED ON. THERE WAS NO KNOWN HISTORY OF GI ISSUES OR RISK FACTORS THAT MAKES PATIENT MORE SUSCEPTIBLE TO GI ISSUES PRIOR TO VNS IMPLANT. THE MEDICAL PROFESSIONAL BELIEVED THAT THE GI ISSUES ARE LIKELY RELATED TO VNS STIMULATION/IMPLANTATION. ATTEMPTS FOR THE DIAGNOSTIC TEST RESULTS WERE MADE BUT THE PATIENT'S VNS WAS REPORTED TO BE PROGRAMMED OFF PRIOR TO THE PATIENT¿S EXPLANT. PATIENT¿S VNS EXPLANT WAS NOT PLANNED TO PRECLUDE A SERIOUS INJURY.

    Description of Event or Problem · 1

    INITIALLY, IT WAS REPORTED THAT THE PATIENT HAD REACHED OUT TO THE SURGEON REQUESTING TO HAVE THE DEVICE EXPLANTED. IT WAS LATER REPORTED THAT THE PATIENT REPORTS A SIGNIFICANT AMOUNT OF GI DISTRESS AND FEELS THAT IT IS LINKED TO VNS. IT WAS REPORTED THAT THE PATIENT FEELS THAT THE LEAD AROUND THE NERVE IS CAUSING OR CONTRIBUTING TO HIS CHRONIC GI UPSET. IT WAS REPORTED THAT THE PHYSICIAN DOES NOT CONFIRM NOR DENY THE PATIENT'S ALLEGATIONS, BUT FEELS THAT THE PATIENT FEELS DISTRESSED ABOUT HAVING VNS IMPLANTED AND HAS NO OBJECTIONS TO REMOVING THE DEVICE. THE PATIENT UNDERWENT VNS EXPLANT. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23198 PULSE GEN MODEL 102 GENERATOR MUZ CYBERONICS, INC. 102 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention