BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1291934 · Received January 20, 2009

    Report

    Report Number
    1644487-2009-00126
    Event Type
    Injury
    Date Received
    January 20, 2009
    Date of Event
    January 1, 2006
    Report Date
    December 23, 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

    R.PRATAP, A. FARBOUD, H. PATEL, P. MONTGOMERY: 2008: VAGAL NERVE STIMULATOR IMPLANTATION: THE OTOLARYNGOLOGIST'S PERSPECTIVE: EUR ARCH OTORHINOLARYNGOL DOI 10. 1007/S00405-008-0887-2.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE THAT ONE PT OUT OF A GROUP OF TWELVE EXPERIENCED INTRAOPERATIVE BRADYCARDIA DURING THE INTRAOPERATIVE SYSTEMS DIAGNOSTICS TEST. THE EVENT WAS REPORTED AS TRANSIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL UNK NONE LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R