BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2435654 · Received February 2, 2012

    Report

    Report Number
    1644487-2012-00260
    Event Type
    Injury
    Date Received
    February 2, 2012
    Date of Event
    December 1, 2011
    Report Date
    January 3, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, CYBERONICS, OR CYBERONICS; EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR MALFUNCTIONS. THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND CYBERONICS OBJECTS TO THEIR USE.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE PHYSICIAN REVEALS THAT THE SUICIDE ATTEMPT IS NOT BELIEVED TO BE RELATED TO VNS AND IS RELATED TO THE REDUCED ECT REGIMEN. THE LEVEL OF SUICIDE ATTEMPTS IS BELOW PRE-VNS BASELINE LEVELS. THE ONLY CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS THAT PRECEDED THE ONSET OF THE EVENT WAS THE REDUCTION IN FREQUENCY OF ECT. THE PHYSICIAN PLANS TO PERFORM AN ECT SERIES FOLLOWED BY MORE FREQUENT MAINTENANCE ECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD ONE SERIOUS SUICIDAL GESTURE OR ATTEMPT RECENTLY, DURING WHICH THE MEDICAL THREAT TO LIFE WAS MODERATE. REPORTEDLY, THE PATIENT HAS NO SUICIDAL TENDENCIES NORMALLY. 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 GENERATOR MUZ CYBERONICS INC 102 200670

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening