BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 1102488 · Received August 8, 2008

    Report

    Report Number
    1644487-2008-01809
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    January 1, 2001
    Report Date
    July 8, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AZIZ, E, RADCLIFFE, J.J. "VAGAL NERVE STIMULATORS AND ANAESTHESIA: 1." ANAESTHESIA 2001; 56: 1209.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE REVIEWED BY MANUFACTURER THAT THE VNS PATIENT EXPERIENCED AN ASYSTOLE EVENT INTRA-OPERATIVELY UPON INITIAL IMPLANT OF THE VNS DEVICE, DURING LEAD TEST. THE FOLLOWING IS THE SUMMARY OF THIS PATIENTS EVENT ACCORDING TO THE INFORMATION IN THE REFERENCED ARTICLE. IT WAS REPORTED IN THE LITERATURE THAT THE VNS PATIENT EXPERIENCED ASYSTOLE INTRAOPERATIVELY, UNDER ANESTHESIA, FROM WHICH THE PATIENT RECOVERED UNEVENTFULLY AFTER STOPPING THE STIMULATOR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ARE UNDERWAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R