BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2880382 · Received December 19, 2012

    Report

    Report Number
    1644487-2012-03406
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    September 24, 2012
    Report Date
    November 26, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    RELEVANT TESTS/LABORATORY DATA - CORRECTED DATA: THE PATIENT'S SETTINGS AND DIAGNOSTIC RESULTS, AVAILABLE AT THE TIME OF THE INITIAL REPORT WERE INADVERTENTLY OMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTES RECEIVED ON (B)(6) 2012 THAT THE PATIENT HAS OBSTRUCTIVE SLEEP APNEA WITH AN OXYGEN DESATURATION AS LOW AS 65%. THIS WAS FIRST DIAGNOSED DURING TESTING ON (B)(6) 2012; HOWEVER OBSTRUCTIVE SLEEP APNEA WAS SUSPECTED IN A CLINIC NOTE DATED (B)(6) 2012. THE SLEEP APNEA IS BEING TREATED BY CPAP. IT IS CURRENTLY UNKNOWN IF THE APNEA IS RELATED TO VNS. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN DOES NOT BELIEVE THAT THERE IS ANY RELATIONSHIP BETWEEN VNS THERAPY AND THE PATIENT'S SLEEP APNEA. THE APNEA WAS NOT OCCURRING WITH STIMULATION AND THERE WERE NO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDE THE ONSET OF THE SLEEP APNEA. PER THE PHYSICIAN, HE SUSPECTED THAT THE PATIENT'S SLEEP APNEA PRE-EXISTED TREATMENT WITH VNS THERAPY, HOWEVER HE WAS UNCERTAIN AS HE ONLY STARTED SEEING THE PATIENT IN SEPTEMBER. IT WAS NOTED THAT THE PATIENT IS DOING GREAT WITH CPAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 200969

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention