BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2397423 · Received January 4, 2012

    Report

    Report Number
    1644487-2012-00023
    Event Type
    Injury
    Date Received
    January 4, 2012
    Date of Event
    October 21, 2011
    Report Date
    December 5, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED HE DID NOT SEE THE PATIENT AT THE TIME OF THE SUICIDAL GESTURE, AND RECOMMENDED THE MANUFACTURER FOLLOW UP WITH THE TREATING PHYSICIAN. FOLLOW UP WITH THE TREATING PHYSICIAN REVEALED THE SUICIDAL GESTURE WAS UNRELATED TO VNS, AND THE PHYSICIAN WAS AWARE OF THE PATIENT'S SUICIDAL GESTURE AT THE TIME. THE PHYSICIAN STATED VNS HAS BEEN VERY HELPFUL FOR THE PATIENT.

    Description of Event or Problem · 1

    REPORTER INDICATED VIA A SUICIDE ASSESSMENT FORM RECEIVED TO THE MANUFACTURER THAT A VNS PATIENT MADE A SUICIDAL GESTURE ON (B)(6) 2011. THE EVENT WAS DESCRIBED AS MINIMAL AND ONLY INVOLVING THOUGHTS, NO ACTIONS. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 PULSE GEN MODEL 102 MUZ CYBERONICS INC 102 200677

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention