BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2841905 · Received November 21, 2012

    Report

    Report Number
    1644487-2012-03088
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 24, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 NOTE THAT WHILE DIAGNOSTIC RESULTS INDICATED THE BATTERY IS NOT COMPLETELY DEAD, THE PATIENT'S DEVICE IS UNABLE TO DELIVER STIMULUS AT THE HIGH SETTINGS THE PATIENT HAS BEEN PROGRAMMED ON. AS THE DEVICE WAS GREATER THAN NINE YEARS OLD AS WELL, THE PHYSICIAN REFERRED THE PATIENT FOR A BATTERY REPLACEMENT. THE REPLACEMENT SURGERY TOOK PLACE ON (B)(6) 2012. ADDITIONALLY, CLINIC NOTES STATED THAT THE PATIENT EXPERIENCED A 'FLURRY OR SEIZURES' AND COMPLAINED OF A SORE THROAT WITH VNS STIMULATION. THE PATIENT'S MEDICATION WAS INCREASED AS A TREATMENT OPTION, AND IT WAS NOTED THAT THE INCREASED SEIZURES WAS MOST LIKELY RELATED TO BATTERY FAILURE OF THE VNS DEVICE. FOLLOW UP WITH THE PHYSICIAN FOUND THAT THE PATIENT'S INCREASE IN SEIZURES WERE FIRST OBSERVED ON (B)(6) 2012 AND IT WAS UNKNOWN WHEN THE SORE THROAT WAS FIRST OBSERVED. THE INCREASED SEIZURES WERE ATTRIBUTED TO THE BATTERY BEING UNABLE TO DELIVER STIMULUS AT HIGH SETTINGS; HOWEVER, THE INCREASED SEIZURE FREQUENCY WAS NOTED TO BE BELOW PRE-VNS BASELINE LEVEL. THE BATTERY REPLACEMENT WAS PERFORMED AS INTERVENTION FOR THE INCREASE IN SEIZURES, SORE THROAT, AND LOWERED OUTPUT CURRENT. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDED EITHER EVENT. NO PATIENT MANIPULATION OR TRAUMA OCCURRED WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE SORE THROAT AND THE PATIENT DID NOT HAVE MULTIPLE SEIZURE TYPES.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE HOSPITAL FOUND THAT THE DEVICE HAD LIKELY BEEN DISCARDED AS THEY COULD NOT FIND IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 8625

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR