BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2983595 · Received February 28, 2013

    Report

    Report Number
    1644487-2013-00556
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    April 17, 2007
    Report Date
    February 5, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 CLINIC NOTES WERE RECEIVED. REVIEW OF THE CLINIC NOTES DATED (B)(6) 2007 INDICATE THAT THE PATIENT HAS OBSTRUCTIVE SLEEP APNEA AND USES A CPAP EVERY NIGHT. CLINIC NOTES DATED (B)(6) 2008 INDICATE THAT THE PATIENT IS STILL USING CPAP AND FEELS FINE WITH IT. THE CLINIC NOTES ALSO MENTION THAT THE PATIENT HAS BEEN HAVING VERY STRONG HEADACHES SINCE A MONTH AGO AND WAS TAKEN TO THE HOSPITAL ON (B)(6) 2008 FOR STRONG HEAD PAIN AND WAS TOLD THAT SHE HAD A MIGRAINE. IT WAS STATED THAT LIGHT, NOISE, AND T.V. PROVOKE HER HEADACHES. THE PHYSICIAN LATER REPORTED THAT THE SLEEP APNEA WAS FIRST OBSERVED ON (B)(6) 2007 AND THAT THE VNS APPEARS TO HAVE WORSENED THE SLEEP APNEA. THE SLEEP APNEA SOMETIMES OCCURS WITH STIMULATION, BUT NOT ALWAYS. THE ONLY INTERVENTION IS THAT THE PATIENT USES CPAP NIGHTLY. THE PATIENT'S SLEEP APNEA WAS DIAGNOSED PRIOR TO VNS BUT THE LAST SLEEP STUDY IN 2012 SHOWED HER SLEEP APNEA IS SUBSTANTIALLY WORSE THAN IN 2007. IT WAS ALSO NOTED THAT THE PATIENT HAD A HEART MURMUR AND ACID REFLUX PRIOR TO BEING IMPLANTED WITH VNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87107 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 2214

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention