BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2251406 · Received September 13, 2011

    Report

    Report Number
    1644487-2011-02150
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 7, 2011
    Report Date
    August 15, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ATTEMPTS TO OBTAIN THE EXPLANTED DEVICE HAVE BEEN UNSUCCESSFUL TO DATE AS THE PHYSICIAN DOES NOT RECALL THE REPLACEMENT SURGERY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A COMPANY REP THAT A VNS PT EXPERIENCED AN INCREASE IN SEIZURES AFTER INITIALLY RESPONDING WELL TO VNS THERAPY. THE PT'S PROGRAMMED SETTINGS WERE 1.75 MA AND SYSTEM DIAGNOSTICS WERE WITHIN NORMAL LIMITS (OK/OK/2/NO). ADD'L INFO WAS RECEIVED FROM THE AREA REP INDICATING THAT THE PT BEGAN HAVING A WORSENING IN SEIZURES IN THE BEGINNING OF (B)(6). THE TREATING PHYSICIAN INDICATED THAT THE PT'S INCREASE IS OF UNK CAUSE AND POSSIBLE CAUSES COULD BE BATTERY DEPLETION AND/OR PT'S WORSENING CONDITION. INTERVENTIONS TAKEN WERE TO REPROGRAM THE PT TO OTHER DEVICE SETTINGS IN HOPES TO RE-ESTABLISH SEIZURE CONTROL. A PRE-VNS BASELINE FOR SEIZURES WAS UNK AND FUTURE PLANS ARE TO REPLACE THE PT'S GENERATOR SINCE END OF SERVICE MIGHT BE NEAR.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THROUGH AN IMPLANT CARD INDICATING THE PATIENT UNDERWENT PROPHYLACTIC GENERATOR REPLACEMENT SURGERY. GOOD FAITH ATTEMPTS TO OBTAIN THE EXPLANTED DEVICE RETURNED FOR ANALYSIS REMAINS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 016869

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention