BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2093644 · Received May 12, 2011

    Report

    Report Number
    1644487-2011-01071
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, CLINIC NOTES FROM A VNS TREATING PHYSICIAN WERE RECEIVED BY CASE MANAGEMENT. REVIEW OF CLINIC NOTES DATED (B)(6) 2011 REVEALED THAT THE PT WAS EXPERIENCING SOMNOLENCE AND CLINIC NOTES DATED (B)(6) 2011 STATE THAT THE PT WAS BEING SENT TO A SLEEP STUDY BECAUSE SHE WAS EXPERIENCING SLEEP APNEA. CLINIC NOTES DATED (B)(6) 2011 STATE THAT DIAGNOSTICS SHOWED THAT THE GENERATOR WAS AT END OF LIFE AND THE PT IS BEING REFERRED FOR BATTERY REPLACEMENT. ADDITIONAL INFORMATION REGARDING THE PT'S SLEEP APNEA HAS BEEN REQUESTED FROM THE PHYSICIAN; HOWEVER NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. BATTERY REPLACEMENT SURGERY IS LIKELY SOON BUT HAS NOT BEEN SCHEDULED YET. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 200786

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention