BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3033404 · Received April 3, 2013

    Report

    Report Number
    1644487-2013-00902
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE VNS PATIENT HAS BEEN FEELING ERRATIC STIMULATION THAT STARTED ABOUT THREE WEEKS AGO AROUND (B)(6) 2013. THERE HAVE NOT BEEN ANY RECENT CHANGES IN PARAMETER SETTINGS OR MEDICATIONS. THERE ALSO HAS NOT BEEN ANY RECENT TRAUMA OR PATIENT MANIPULATION OF THE DEVICE. DIAGNOSTICS SHOWED THE DEVICE TO BE FUNCTIONING PROPERLY. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 4.62 YEARS REMAINING UNTIL ERI=YES. IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013, FOR PROPHYLACTIC REASONS. IT WAS REPORTED THAT THE GENERATOR WOULD BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS BUT IT HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN THE EXPLANTED GENERATOR WAS RETURNED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE HAD EXPERIENCED SYNCOPE EPISODES WITH THE DEVICE AND THAT THE GENERATOR HAD BEEN AT END OF SERVICE. THE PATIENT INDICATED THAT THESE SYNCOPE EPISODES ALSO OCCURRED WHEN HER PACKEMAKER DIED TOO; SHE ALSO HAS A RIGHT SIDED PACEMAKER IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE NEUROLOGIST THAT THE PATIENT'S SYNCOPE COULD BE RELATED TO COMPLAINT OF FREQUENT DISCHARGES FROM VNS DEVICE. THE PATIENT WAS REFERRED FOR GENERATOR REPLACEMENT BECAUSE OF THE SYNCOPE. NO DIAGNOSTIC TEST RESULTS OR SETTINGS WERE PROVIDED. IT IS UNKNOWN IF THERE WERE ANY OTHER CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDE THE ONSET OF THE SYNCOPE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. IN THE PRODUCT ANALYSIS LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR'S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS; THERE WERE NO ANOMALIES FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136288 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 7668

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention