BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 4108117 · Received September 22, 2014

    Report

    Report Number
    1644487-2014-02426
    Event Type
    Injury
    Date Received
    September 22, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 19, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURES AND NEEDED TO HAVE THE GENERATOR REPLACED DUE TO THE BATTERY BEING CRITICALLY LOW. THE PATIENT UNDERWENT GENERATOR REPLACEMENT. THE IMPLANT CARD WAS RECEIVED WHICH INDICATED THAT THE GENERATOR WAS REPLACED PROPHYLACTICALLY AND WAS NEOS - NO. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANTED GENERATOR HAS NOT BEEN RECEIVED FOR ANALYSIS TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT DID NOT HAVE ANY MEDICATION CHANGES OR ANY OTHER FACTORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE RELATIONSHIP OF THE INCREASE IN SEIZURES TO PRE-VNS BASELINE LEVELS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588224 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016174

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention