BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 1143660 · Received August 28, 2008

    Report

    Report Number
    1644487-2008-01873
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    June 19, 2003
    Report Date
    July 31, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE REFERENCE: MARZEC, MARY, JONATHAN EDWARDS, OREN SAGHER, GAIL FROMES, AND BETH A. MALOW. "EFFECTS OF VAGUS NERVE STIMULATION ON SLEEP-RELATED BREATHING IN EPILEPSY PATIENTS." EPILEPSIA 44 (2003): 930-35.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A SCIENTIFIC ARTICLE THAT A VNS PATIENT, WHOSE PREEXISTING OBSTRUCTIVE SLEEP APNEA HAD BEEN EXACERBATED BY VNS STIMULATION, REQUIRED CPAP TREATMENT TO PRECLUDE POTENTIAL ADVERSE EVENTS. GOOD FAITH ATTEMPT FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention