BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2851348 · Received November 29, 2012

    Report

    Report Number
    1644487-2012-03145
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 30, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES DATED (B)(6), 2012 THAT THE PATIENT HAS OBSTRUCTIVE SLEEP APNEA FOR WHICH HE USES A CPAP MACHINE. NOTES DATED (B)(6), 2012 REPORT THAT SINCE THE CPAP MACHINE HAS BEEN USED, THE PATIENT'S SLEEP CYCLE HAS BEEN DOING FINE AND THE PATIENT'S HEADACHES HAVE STOPPED. PER THE CLINIC NOTES, THE PATIENT SEEMS TO BE IN NO DISTRESS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE NURSE CALLED TO FOLLOW UP ON THE PATIENT'S SLEEP APNEA. SHE STATED THAT THE PATIENT WAS DIAGNOSED WITH SLEEP APNEA PRIOR TO GETTING VNS AND THAT THE SLEEP APNEA WAS DUE TO THE WAY THE PATIENT HOLDS HIS BODY AND NOT DUE TO ANY DEVICE. SHE STATED THAT THE PATIENT'S CHEST IS CAVED IN FROM HOW HE SITS AND THAT HE WAS TESTED FOR SLEEP APNEA DUE TO HIS POSTURE. THE NURSE FURTHER STATED THAT THE PATIENT WOULD HAVE SLEEP APNEA EVEN IF HE DID NOT HAVE THE DEVICE AND THAT VNS WAS NOT RELATED TO THIS EVENT. IN FACT, IT WAS STATED THAT THE VNS DEVICE HAS BEEN HELPING THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 015168

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention