BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3342359 · Received September 11, 2013

    Report

    Report Number
    1644487-2013-02652
    Event Type
    Injury
    Date Received
    September 11, 2013
    Date of Event
    August 7, 2013
    Report Date
    August 13, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED WHICH INDICATE THE PATIENT CONTINUES TO HAVE SEIZURES FAIRLY REGULARLY, DESPITE MANY DIFFERENT MEDICATIONS. ALL OF THE PATIENT'S MEDICATIONS HAVE DEPRESSANT EFFECTS, WHICH INCLUDE DECREASED COGNITIVE PROCESSING, DECREASED ALERTNESS, AND FATIGUE. ADDITIONALLY, AFTER A SEIZURE IT WAS STATED THAT THE PATIENT CAN HAVE DECREASED LEVEL OF CONSCIOUSNESS AND COGNITION. NOTES DATED (B)(6) 2013 INDICATE THE PATIENT REPORTS THAT HE IS DOING GOOD AND HAS HAD SOME SEIZURES AND SOME BLACKOUTS AT HOME. NOTES DATED (B)(6) 2013 STATE THE PATIENT HAD SEVERAL LONGER BLACKOUTS RECENTLY. LEVELS IN FEBRUARY WERE OK. THERE WERE NO NEW MEDICATIONS PER OTHER PHYSICIANS. DISCUSSION WITH THE PATIENT INDICATED THE PATIENT WANTED A VNS REPLACEMENT VERSUS CHANGES IN MEDICATION. ON (B)(6) 2012, THE PATIENT REPORTED THAT HE HAD "2 BIG ONES" ABOUT A MONTH AGO. THERE WERE NO INJURIES WITH THE SEIZURES. AS THE WORD "SEIZURES" AND "2 BIG ONES" IS QUOTED IN THE CLINIC NOTES, IT IS UNCLEAR IF THE PHYSICIAN BELIEVES THESE EVENTS TO BE SEIZURES. THE NOTES ALSO INDICATE THAT THE PATIENT MAY NOT HAVE BEEN TAKING HIS MEDICATIONS AT THIS TIME AND IN (B)(6) 2012. SURGERY IS LIKELY, BUT HAS NOT TAKEN PLACE. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY HAVE BEEN UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(6) 2013. VISUAL EXAMINATION NOTED TOOL MARKS ON THE GENERATOR CASE AND HEADER MOST LIKELY ASSOCIATED WITH MANIPULATION OF THE DEVICE DURING THE EXPLANT PROCEDURE. BURN MARKS WERE OBSERVED ON THE PULSE GENERATOR CASE INDICATING THAT THE PULSE GENERATOR MAY HAVE BEEN EXPOSED TO AN ELECTROCAUTERY TOOL. NO OTHER SURFACE ABNORMALITIES WERE NOTED ON THIS DEVICE. THE SEPTUM WAS NOT CORED. THE PULSE GENERATOR WAS OPENED. A VISUAL ASSESSMENT OF THE PCB REVEALED NO ANOMALIES. THE ALLEGATIONS WERE DETERMINED TO BE THE RESULT OF NORMAL BATTERY DEPLETION. BASED ON THE ELECTRICAL TEST RESULTS, THE DEVICE EXHIBITED CURRENT CONSUMPTION RATES THAT ARE WITHIN SPECIFICATION, THEREBY DEMONSTRATING NORMAL BATTERY DEPLETION TO AN END-OF-SERVICE CONDITION. THE ELECTRICAL PERFORMANCE OF THE GENERATOR, AS MEASURED IN THE PA LAB, WILL BE USED TO CONCLUDE THAT NO ANOMALIES EXIST AND THE EOS CONDITION IS AN EXPECTED EVENT. THE MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE.

    Description of Event or Problem · 1

    AN IN-HOUSE BATTERY LIFE CALCULATION WITH DATA FROM (B)(6) 2007 TO (B)(6) 2009 RESULTED IN 0 YEARS REMAINING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S DEVICE WAS REPLACED DUE TO BEING UNABLE TO BE COMMUNICATED WITH FROM END OF SERVICE. THE DEVICE WAS RETURNED AND IS PENDING PRODUCT ANALYSIS. ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455871 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 015790

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other