BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2904959 · Received January 9, 2013

    Report

    Report Number
    1644487-2013-00079
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING AND DEVICE DIAGNOSTIC HISTORY PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE MANUFACTURER RECEIVED CLINIC NOTES FOR A VNS PATIENT. IN NOTES DATED (B)(6) 2012 IT STATED THAT THE PATIENT HAS SEVERE LIFETIME MULTIFOCAL EPILEPSY WHICH WORSENED AGAIN IN THE MONTH OF (B)(6) 2012. THE PLAN WAS TO ADD ONFI TO THE PATIENT'S TREATMENT PLAN. IN NOTES DATED (B)(6) 2012 IT INDICATED THAT THE PATIENT HAS EXPERIENCED AN INCREASE IN SEIZURES, ESPECIALLY IN THE AFTERNOON FOR THE LAST 3 MONTHS. THE NOTES STATED THAT THE PHYSICIAN FELT THAT ONFI WAS NOT EFFECTIVE AND THAT THE PATIENT DID NOT RESPOND TO ONFI. THE PHYSICIAN NOTED THAT IN RETROSPECT VIMPAT SEEMED TO HAVE REDUCED THE PATIENT'S SEIZURE FREQUENCY. AT THAT TIME, THE PATIENT WAS ASKED TO DISCONTINUE ONFI AND INCREASE VIMPAT TO 200MG BID. THE PATIENT'S PROGRAMMING HISTORY AVAILABLE TO IN THE MANUFACTURER'S IN-HOUSE PROGRAMMING DATABASE WAS REVIEWED HOWEVER THE DATA ENDS PRIOR TO THE SEIZURES WORSENING IN (B)(6) 2012. GOOD FAITH ATTEMPTS TO OBTAIN MORE INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIANS WERE UNABLE TO DETERMINE THE CAUSE OF THE INCREASED SEIZURES. AS THEY COULD NOT IDENTIFY ANOTHER REASON, THEY FELT THAT IT MAY BE RELATED TO THE BATTERY, HOWEVER THE PATIENT'S BATTERY WAS NOT DEPLETED AT THE TIME. NO OTHER INFORMATION WOULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12231 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 201201

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other