BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR MODEL 104

    MDR report key: 3061037 · Received April 16, 2013

    Report

    Report Number
    1644487-2013-01027
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 18, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2013. ANALYSIS OF THE GENERATOR CONFIRMED A PULSE-DISABLED CONDITION. THE BATTERY MEASURED 1.987 VOLTS, VERIFYING AN EOS CONDITION. THE POST BURN-IN ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR THAT WOULD AFFECT DEVICE PERFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INTERROGATION OF THE DEVICE THE DAY OF GENERATOR REPLACEMENT SURGERY AN EOS < VBAT, PULSE DISABLED WARNING MESSAGE WAS OBSERVED. THE OUTPUT CURRENT WAS NOTED TO BE AT 0MA. IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013 DUE TO END OF SERVICE. THE GENERATOR WAS RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS ON (B)(6) 2013. PRODUCT ANALYSIS IS UNDERWAY; HOWEVER, HAS NOT BEEN COMPLETED TO DATE. THE IMPLANT CARD WAS RECEIVED WHICH CONFIRMED THE DATE OF REPLACEMENT AS (B)(6) 2013 FOR NEOS = YES. THE LEAD IMPEDANCE WAS MARKED "OK".

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 INDICATE THAT THE PATIENT EXPERIENCES MORE FREQUENT SEIZURES. THE NOTES INDICATE THAT VNS THERAPY HAS MADE THE PATIENT FUNCTIONAL; HOWEVER, EVERY THREE WEEKS THE PATIENT EXPERIENCES A GENERALIZED TONIC SEIZURE. IT WAS NOTED THAT THE PATIENT CAN FALL, BUT THAT THE FALLS ARE RARE. THE LONGEST SEIZURES LAST ABOUT THREE MINUTES. IT WAS NOTED THAT TWICE A DAY A SHORTER EVENT OCCURS AS A PARTIAL SEIZURE WHERE HE KICKS HIS LEG, LOSES BLADDER CONTROL AND GRUNT. IT WAS NOTED THAT THE VNS WAS AT NEOS = YES, 2384 OHMS AND THAT REPLACEMENT IS RECOMMENDED. THE PATIENT'S OXCARBAZEPINE WAS INCREASED AT THIS VISIT. THE PATIENT HAS BEEN REFERRED TO SURGERY; HOWEVER, THE SURGERY HAS NOT OCCURRED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162142 PULSE GENERATOR MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 200926

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other