BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3030655 · Received April 2, 2013

    Report

    Report Number
    1644487-2013-00888
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    January 7, 2013
    Report Date
    March 5, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 IT WAS REPORTED THAT THE VNS PATIENT UNDERWENT A GENERATOR REPLACEMENT ON (B)(6) 2013 BECAUSE THE PHYSICIAN WAS UNABLE TO INTERROGATE THE PATIENT'S GENERATOR AT THE LAST CLINICAL VISIT ON (B)(6) 2013. THE HOSPITAL REPORTED THAT THE EXPLANTED GENERATOR COULD NOT BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 1.73 YEARS REMAINING UNTIL ERI=YES. THE MANUFACTURING RECORDS FOR THE GENERATOR WAS REVIEWED, DEVICE MET ALL SPECIFICATIONS PRIOR TO DISTRIBUTION. IT WAS CONFIRMED THAT THE PHYSICIAN'S TWO PROGRAMMING SYSTEMS ARE FUNCTIONING PROPERLY AND HAVE SUCCESSFULLY INTERROGATED OTHER VNS PATIENTS SINCE THE CLINICAL VISIT ON (B)(6) 2013. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION FROM THE PHYSICIAN WERE UNSUCCESSFUL. IT IS UNKNOWN IF THE GENERATOR IS AT END OF SERVICE AND IF THAT IS THE CAUSE OF THE FAILURE TO INTERROGATE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134075 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 200863

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR