BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2872582 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03337
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 13, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD COUGHING RELATED TO VNS WHICH LEAD TO THEM ALMOST PASSING OUT. THE PATIENT HAD THEIR GENERATOR OFF DUE TO THE EVENTS. THE PATIENT DOES NOT HAVE A MEDICAL HISTORY OF THIS PRIOR TO VNS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT AFTER THE OUTPUT CURRENT WAS CHANGED FROM 1.75 MA TO 2.0 MA THE PATIENT COUGHED BADLY AND PASSED OUT. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM . THE PATIENT HAD THEIR OUTPUT CURRENT ADJUSTED BACK TO 1.75 MA AND THEN HAD THE GENERATOR DISABLED. NO FURTHER INFORMATION WAS PROVIDED. GOOD FAITH ATTEMPT FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201757

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention