BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GENERATOR MODEL 103

    MDR report key: 3061072 · Received April 16, 2013

    Report

    Report Number
    1644487-2013-01030
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 19, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS FOR BOTH THE GENERATOR AND LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS GOING TO UNDERGO EXPLANT OF VNS SYSTEM DUE TO THE VNS NOT WORKING. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT WAS SEEN BY THE NEUROLOGIST IN (B)(6) 2013 AT WHICH TIME THE GENERATOR WAS UNABLE TO BE COMMUNICATED WITH. IT WAS REPORTED THAT AT THIS VISIT IT WAS NOTED THAT THE PATIENT WAS NO LONGER ABLE TO FEEL STIMULATION. THE NEUROLOGISTS OFFICE INDICATED THAT THE NOTES FROM THE (B)(6) 2012 VISIT INDICATED THAT THE BATTERY WAS LOW; HOWEVER, NO DIAGNOSTICS WERE NOTED. IT WAS REPORTED THAT THE NOTES INDICATED THAT THE PATIENT'S FAMILY WANTS TO DECREASE THE VNS SETTINGS WITH A GOAL TO DISCONTINUE VNS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SURGERY IS LIKELY; HOWEVER, HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IN FACT ABLE TO BE COMMUNICATED WITH IN (B)(6) 2013 AND A DEVICE MALFUNCTION WAS NOT SUSPECTED. IT WAS REPORTED THAT THE DEVICE OUTPUT CURRENT WAS DECREASED SINCE (B)(6) 2012 TO EVALUATE SEIZURE TOLERANCE SINCE THE PATIENT'S MOTHER WAS UNCERTAIN IF SHE WANTED THE GENERATOR REPLACED SINCE THE BATTERY WAS DEPLETED. SURGERY HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162228 PULSE GENERATOR MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2565

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR