BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2000316 · Received February 18, 2011

    Report

    Report Number
    1644487-2011-00309
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    November 1, 2005
    Report Date
    January 20, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CHRISTANCHO P, CHRISTANCHO M, ET AL EFFECTIVENESS AND SAFETY OF VAGUS NERVE STIMULATION FOR SEVERE TREATMENT-RESISTANT DEPRESSIONS IN CLINICAL PRACTICE AFTER FDA APPROVAL: OUTCOMES AT 1 YEAR. J CLIN PSYCHIATRY. 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AR ARTICLE TITLED "EFFECTIVENESS AND SAFETY OF VAGUS NERVE STIMULATION FOR SEVERE TREATMENT-RESISTANT DEPRESSION IN CLINICAL PRACTICE AFTER FDA APPROVAL: OUTCOMES AT 1 YEAR" THAT A PT HAD ATTEMPTED SUICIDE WHILE RECEIVING VNS THERAPY. IT WAS NOTED THAT THE MEAN NUMBER OF ATTEMPTS HAD DECREASED FROM 0.20 PER PT PER YEAR T0 0.13 ATTEMPTS PER PT PER YEAR THE YEAR AFTER VNS IMPLANT ACCORDING TO THE STUDY. ATTEMPTS WILL BE MADE TO CONFIRM IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED TO THE MANUFACTURER AS PT INFORMATION IS UNK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening