BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2863969 · Received December 10, 2012

    Report

    Report Number
    1644487-2012-03216
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 2, 2012
    Report Date
    November 28, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6), 2013 WHEN IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT GENERATOR REPLACEMENT SURGERY THAT DAY DUE TO THE GENERATOR BEING COMPLETELY DEPLETED. THE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS ON (B)(6), 2013. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS REPORTED THAT THE PHYSICIAN HAS NO FURTHER INFORMATION TO PROVIDE ABOUT THE PATIENT'S INCREASE IN SEIZURES. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURES OF 5-6 SEIZURES A DAY. IT WAS PREVIOUSLY REPORTED ON (B)(6) 2012, THAT THE PATIENT'S VNS BATTERY WAS LOW AND NEEDED TO BE REPLACED. THE PATIENT'S HUSBAND HAD NOT NOTICED A CHANGE IN THE PATIENT'S SEIZURES AT THAT TIME. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 0 YEARS REMAINING UNTIL ERI=YES. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN ARE UNDERWAY BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE REPORTED 'END OF SERVICE' ALLEGATION WAS DUPLICATED IN THE PRODUCT ANALYSIS LABORATORY AND DETERMINED TO BE THE RESULT OF NORMAL EXPECTED BATTERY DEPLETION, BASED ON THE BATTERY LIFE ANALYSIS AND ELECTRICAL TEST RESULTS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 1970

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR