BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2852882 · Received November 30, 2012

    Report

    Report Number
    1644487-2012-03152
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    May 21, 2012
    Report Date
    November 1, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 REVEALED THAT THE PATIENT HAS EXPERIENCED SEVERAL SEIZURES SINCE HER PRIOR VISIT ON (B)(6) 2012. CLINIC NOTES DATED (B)(6) 2012, REVEALED THAT THE PATIENT HAS BEEN EXPERIENCING AN INCREASE IN SEIZURES. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT SUFFERED A FALL DURING A SEIZURE ON (B)(6) 2012, WHICH RESULTED IN A FRACTURE OF THE DISTAL RADIUS. THE PHYSICIAN BELIEVES THAT THE DEVICE MAY BE NEARING END OF SERVICE AND HAS RECOMMENDED THE PATIENT FOLLOW-UP WITH THE CARDIOLOGIST FOR AN EKG PRIOR TO DEVICE REPLACEMENT. THE PATIENT HAS A HISTORY OF ARRHYTHMIA AS REFERENCED IN MFR REPORT # 1644487-2012-03150.

    Description of Event or Problem · 1

    THE IMPLANT CARD WAS RECEIVED WHICH REPORTED THE PATIENT HAD PROPHYLACTIC GENERATOR REPLACEMENT ON (B)(6) 2012. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN REFERRED FOR GENERATOR REPLACEMENT SURGERY, HOWEVER THE SURGERY HAS NOT OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE EXPLANTING FACILITY REPORTING THAT THEY NO LONGER HAVE THE EXPLANTED GENERATOR, AND THEREFORE, IT WILL NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 200759

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R