BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2810363 · Received October 31, 2012

    Report

    Report Number
    1644487-2012-02816
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    May 29, 2012
    Report Date
    October 3, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON (B)(6) 2012, THAT THIS VNS PATIENT HAD A HISTORY OF SLEEP APNEA. THE SLEEP APNEA WAS NOT BELIEVED TO BE RELATED TO VNS.

    Description of Event or Problem · 1

    CLINIC NOTES REGARDING THIS VNS PATIENT WERE RECEIVED ON (B)(6) 2012. NOTES DATED (B)(6) 2012 INDICATED THAT THIS VNS PATIENT HAD OBSTRUCTIVE SLEEP APNEA. THE PATIENT WAS REPORTED TO BE DOING WELL ON BIPAP. THE PATIENT'S DEVICE WAS INTERROGATED AND ADJUSTED. (THE PULSEWIDTH WAS LIKELY A TYPOGRAPHICAL ERROR AS 350 USEC IS NOT A PULSEWIDTH OPTION.) THE PATIENT TOLERATED THE PROCEDURE WELL AND LEFT THE OFFICE IN A STABLE CONDITION. CLINIC NOTES DATED (B)(6) 2012 ALSO INDICATED THAT THE PATIENT HAD SEVERE OBSTRUCTIVE SLEEP APNEA. THE PATIENT'S VNS WAS ALSO ADJUSTED ON THIS DATE, AND THE PATIENT TOLERATED THE ADJUSTMENT WITHOUT DIFFICULTY. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200704

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention