BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 6648942 · Received June 16, 2017

    Report

    Report Number
    1644487-2017-03998
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    May 1, 2017
    Report Date
    October 8, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT TO CONSULT WITH SURGEON AND DEVICE WAS CHECKED. THE DEVICE WAS CONFIRMED TO NOT BE NEAR END OF SERVICE AND SO THERE ARE NO PLANS TO REPLACE THE GENERATOR AT THIS TIME.

    Description of Event or Problem · 1

    PHYSICIAN IS REFERRING PATIENT FOR VNS BATTERY REPLACEMENT BASED ON DIAGNOSTIC TEST RESULTS THAT MAY INDICATE THAT THE PROGRAMMED OUTPUT CURRENT WAS NOT BEING DELIVERED. SYSTEM DIAGNOSTICS WERE PERFORMED WITH OUTPUT CURRENT OF 1 MA (PROGRAMMED 2.0MA). THESE RESULTS ARE NORMAL AND EXPECTED FOR A SYSTEM DIAGNOSTIC TEST. BUT PER NEUROLOGIST LOW OUTPUT STATUS WAS OBSERVED. CLINIC NOTES WERE RECEIVED THAT INDICATE THAT "LOW OUTPUT CURRENT DELIVERED MIGHT BE THE REASON FOR SEIZURES AT THIS POINT". IT IS UNKNOWN IF PATENT'S SEIZURES ARE ABOVE OR BELOW PRE-VNS BASELINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN AGAIN REFERRED THE PATIENT FOR GENERATOR REPLACEMENT DUE TO BELIEVED LOW OUTPUT CURRENT. SYSTEM DIAGNOSTICS WERE PERFORMED WITH OUTPUT CURRENT OF 1 MA (PROGRAMMED 2.0 MA). THESE RESULTS ARE NORMAL AND EXPECTED FOR A SYSTEM DIAGNOSTIC TEST. NO KNOWN RELEVANT SURGICAL INTERVENTION HAS OCCURRED TO DATE. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REPLACED PROPHYLACTICALLY. RETURN OF THE EXPLANTED PRODUCT IS NOT EXPECTED. PREOPERATIVE SYSTEM DIAGNOSTICS TAKEN BY A COMPANY REPRESENTATIVE SHOWED THAT THE PATIENT'S OUTPUT CURRENT WAS NORMAL. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427697 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 2183

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention