BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3012543 · Received March 20, 2013

    Report

    Report Number
    1644487-2013-00742
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    November 7, 2012
    Report Date
    February 19, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED TO THE MANUFACTURER ON 07/24/2013 INDICATING THE 05/01/2013 VNS GENERATOR REPLACEMENT SURGERY WAS PROPHYLACTIC.

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATENT'S RECENT INCREASE IN SEIZURES MAY BE RELATED TO A DEPLETING VNS BATTERY. THE SEIZURE LEVEL WAS BELOW THE PATIENT'S PRE-VNS BASELINE SEIZURE LEVEL, AND MORE THAN ONE SEIZURE TYPE WAS INCREASED BUT NOT SPECIFIED. NO CAUSAL OR CONTRIBUTORY VNS PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDE THE ONSET OF THE SEIZURE INCREASE.

    Description of Event or Problem · 1

    THE PATIENT HAD VNS GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. THE EXPLANTED GENERATOR WAS DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT EXPERIENCED INCREASED SEIZURES OVER THE LAST SEVERAL MONTHS, AND THAT CURRENTLY THE PATIENT'S VNS IS AT END OF SERVICE (EOS), WITH THE EOS FLAG SHOWING EOS = YES. AS IT IS NOT KNOWN HOW LONG THE EOS FLAG HAS BEEN PRESENT, IT IS UNKNOWN IF THE INCREASE IN SEIZURES IS RELATED TO THE EOS = YES ISSUE. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS. SURGERY TO REPLACE THE VNS GENERATOR IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116473 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 016318

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other