BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1933759 · Received December 16, 2010

    Report

    Report Number
    1644487-2010-02818
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    January 1, 2009
    Report Date
    November 18, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY PHYSICIAN THAT THE PT HAD AN INCREASE IN SEIZURES A YEAR AGO, UNK IF ABOVE OR BELOW BASELINE. PHYSICIAN DID NOT BEGIN SEEING PT UNTIL AFTER VNS WAS IMPLANTED SO THE SEIZURE FREQUENCY PRIOR TO VNS WAS UNK. THE PHYSICIAN STATED THE CHART INDICATED A "SLIGHT INCREASE IN SEIZURES" AND SHE WAS UNSURE OF THE RELATIONSHIP TO VNS AS THEY ARE NOT SURE IF THERE WERE OTHER CONTRIBUTORY FACTORS THAT PRECEDED THE ONSET OF THE INCREASE IN SEIZURES. THE PT OUTPUT CURRENT WAS INCREASED AND THE INCREASE IN SEIZURES RESOLVED. RECENTLY, PT REC'D HIGH IMPEDANCE DURING DIAGNOSTICS, REPORTED IN MDR 1644487-2010-02817.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 014865

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention