BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 3081093 · Received April 26, 2013

    Report

    Report Number
    1644487-2013-01151
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    February 4, 2013
    Report Date
    March 5, 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

    THE REPORTED "FAILURE TO PROGRAM" AND "END OF SERVICE" WERE 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.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED THAT A VNS PATIENT WAS GOING TO BE HAVING THEIR GENERATOR REPLACED FOR NORMAL END OF SERVICE (EOS). REPORTED AT THEIR (B)(6) 2013 VISIT WAS THAT SINCE THE PATIENT'S BATTERY HAS BEEN LOW THEY HAD ABOUT 3 EPILEPSY EPISODES LAST WEEK. THE PATENT'S DEVICE WAS UNABLE TO BE INTERROGATED AS AT END OF BATTERY LIFE. THE PATIENT WENT TO SURGERY (B)(6) 2013 AND THEIR SURGERY WAS ABORTED AFTER BEING UNDER ANESTHESIA BECAUSE THE OR STAFF DID NOT HAVE A COMPATIBLE GENERATOR WITH THEIR IMPLANTED LEAD. TEACHING HAS BEEN PROVIDED TO THE IMPLANTING FACILITY AND THE PATIENT DID UNDERGO SUCCESSFUL GENERATOR REPLACEMENT AT A LATER DATE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181989 PULSE GEN MODEL 102R PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 013755

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R