BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 5016968 · Received August 19, 2015

    Report

    Report Number
    1644487-2015-05556
    Event Type
    Injury
    Date Received
    August 19, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 27, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE UDI: (B)(4). ADDITIONAL MANUFACTURER NARRATIVE AND/OR CORRECTED DATA, CORRECTED DATA: SUSPECT DEVICE UDI: (B)(4). THE SUSPECT DEVICE UDI WAS INADVERTENTLY NOT PROVIDED IN THE INITIAL MDR.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT #1 INADVERTENTLY DOES NOT STATE THE AWARE DATE. THE AWARE DATE OF THE PREVIOUS MDR IS (B)(4) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS PROGRAMMED ON INITIALLY ON WEDNESDAY (B)(6) 2015. ON (B)(6) 2015, PATIENT EXPERIENCED NAUSEA, VOMITING AND SEIZURES. PATIENT VISITED THE ER AND WAS FOUND TO HAVE E-LYE IMBALANCE AS WELL AS LOW BP WITH SYSTOLIC 80. PATIENT WAS GIVEN IF FLUIDS AND MG++ AND K+ AND WAS SENT HOME. PATIENT HAS NOT HAD FURTHER SEIZURES BUT HAD VOMITING AGAIN. CLINIC NOTES FORM THE ER VISIT INDICATE THAT THE PATIENT'S LAST SEIZURE PRIOR TO VNS IMPLANT WAS IN (B)(6). PATIENT EXPERIENCED TWO SEIZURES ON (B)(6) 2015 AND TWO ON (B)(6) 2015. TESTS INDICATE THAT THE PATIENT HAS SLIGHTLY ELEVATED CREATININE, SECONDARY TO DEHYDRATION. PATIENT HAD RECEIVED ALMOST TWO LITERS OF FLUID WITH IMPROVEMENT IN HER BLOOD PRESSURE. ON (B)(6) 2015, IT WAS STATED THAT THE PATIENT IS FEELING BETTER. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WERE UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546891 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 203260

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention