BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2880629 · Received December 19, 2012

    Report

    Report Number
    1644487-2012-03381
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 INDICATE THAT THE PATIENT HAS HAD "SEVERE SEIZURES" IN THE PAST WHEN THE VNS IS NOT WORKING PROPERLY. THE DATE OF THESE EVENTS AND THE ISSUE THAT CAUSED THE VNS TO NOT WORK PROPERLY IS UNKNOWN. IT IS UNKNOWN IF THE EVENT IS BEING RELATED TO THEIR BATTERY STATUS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. CURRENTLY THEIR VNS IS AT END OF BATTERY LIFE AND UNABLE TO BE INTERROGATED RELATED TO THAT. THEIR EXPLANTED GENERATOR HAS BEEN RETURNED FOR ANALYSIS AND COMPLETION IS PENDING.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS ON THE EXPLANTED GENERATOR FOUND THAT THE DEVICE WAS AT END OF SERVICE DUE TO NORMAL BATTERY DEPLETION. THE DEPLETION WAS AN EXPECTED EVENT AS DETERMINED BY THE BATTERY LIFE CALCULATION AND BATTERY VOLTAGE MEASUREMENT. THE MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AS DEFINED IN POST BURN-IN ELECTRICAL TEST. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE. FOLLOW UP WITH THE PHYSICIAN FOUND THAT THERE WERE NO SEVERE SEIZURES EXPERIENCED BY THE PATIENT. THE PATIENT EXPERIENCED A SLIGHT INCREASE IN SEIZURES ON (B)(6) 2012 THAT WAS BELOW PRE-VNS BASELINE LEVELS. THE PATIENT DOES NOT HAVE MULTIPLE SEIZURE TYPES AND NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR EXTERNAL FACTORS CONTRIBUTED TO THE ONSET OF THE SEIZURES. IT WAS FOUND THAT THE BELIEF THAT THE DEVICE WAS NOT WORKING PROPERLY WAS IN REFERENCE TO THE DEVICE BEING AT END OF SERVICE (EOS). THE VNS WAS CHECKED ON (B)(6) 2012 AND COULD NOT BE INTERROGATED DUE TO THIS EOS. THE ONLY INTERVENTION TAKEN WAS THE BATTERY REPLACEMENT ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 200774

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR