BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL

    MDR report key: 2356182 · Received December 2, 2011

    Report

    Report Number
    1644487-2011-02924
    Event Type
    Injury
    Date Received
    December 2, 2011
    Date of Event
    November 6, 2011
    Report Date
    November 6, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS BEING IMPLANTED WITH A PACEMAKER BY ANOTHER COMPANY REPRESENTATIVE. THE OTHER'S COMPANY REPRESENTATIVE DID NOT KNOW IF THE REASON THE PATIENT WAS BEING IMPLANTED WITH A PACEMAKER WAS RELATED TO VNS, BUT DID PROVIDED THE TREATING CARDIOLOGIST NAME. FOLLOW-UP WITH THE CARDIOLOGIST THAT THE OTHER'S COMPANY REPRESENTATIVE PROVIDED HAD NO RECORD OF THE PATIENT SEEING OR PLANNING ON SEEING ANYONE IN THEIR PRACTICE. IT IS STILL UNKNOWN IF THE REASON FOR THE PATIENT WAS BEING IMPLANTED WITH A PACEMAKER IS RELATED TO VNS. (B)(4) ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL GENERATOR MUZ CYBERONICS INC 102 012991

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention