BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2781634 · Received October 10, 2012

    Report

    Report Number
    1644487-2012-02578
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    April 17, 2012
    Report Date
    September 10, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FORM THE SURGEON'S OFFICE INDICATING THAT THEY HAD NOT HEARD OF ANY HEART RATE OR ARRHYTHMIA ISSUES DURING THE IMPLANT SURGERY. THE SITE ALSO CHECKED THE OPERATIVE REPORT WHICH INDICATED NO ISSUES AND EVERYTHING WAS NORMAL. THE OPERATIVE REPORT SPECIFICALLY NOTED "COMPLICATIONS: NONE." THE SURGEON'S OFFICE INDICATED THAT IT IS LIKELY THAT THE PATIENT'S MOTHER LIKELY MISHEARD THE ANESTHESIOLOGIST. ALL DIAGNOSTICS WERE NORMAL DURING THE SURGERY PER THE OPERATIVE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VNS PATIENT'S MOTHER THAT DURING THE INITIAL IMPLANT SURGERY, SHE OVERHEARD THE ANESTHESIOLOGIST COMMENT ABOUT A PROBLEM WITH THE PATIENT'S HEART RATE DURING THE PROCEDURE. THE PATIENT'S NEUROLOGIST REPORTEDLY WAS NOT AWARE OF THE ISSUE. A COMPANY REPRESENTATIVE WAS PRESENT AT THE IMPLANT SURGERY HOWEVER SHE WAS NOT NOTIFIED OF THE ISSUE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201984

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening