BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 4222736 · Received November 4, 2014

    Report

    Report Number
    1644487-2014-02910
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    August 1, 2014
    Report Date
    October 13, 2014
    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
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT; CORRECTED DATA: ADDITIONAL INFORMATION WAS RECEIVED THAT CHANGES THE DATE THAT WAS ORIGINALLY REPORTED ON INITIAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014 THE PHYSICIAN REPORTED THAT THERE WAS NO CORRELATION BETWEEN THE INCREASE IN SEIZURES AND THE VNS. THE ONLY INTERVENTION TAKEN WAS TO ADD VIMPAT MEDICATION. IT WAS NOT KNOWN WHAT THE RELATIONSHIP OF THE INCREASE IN SEIZURE FREQUENCY WAS TO PRE-VNS BASELINE LEVELS. IT WAS ALSO UNKNOWN IF ANY CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDE THE ONSET OF THE INCREASE IN SEIZURES. THE PATIENT¿S MOTHER HAD REPORTED THAT THE FREQUENCY OF SEIZURES HAD INCREASED SINCE THREE MONTHS PRIOR.

    Description of Event or Problem · 1

    ON (B)(6), 2014 IT WAS REPORTED THAT THE PATIENT IS HAVING AN INCREASE IN SEIZURES AND THE PATIENT¿S MOTHER ATTRIBUTES IT TO THE VNS BATTERY BEING LOW OR AT END OF SERVICE. IT WAS REPORTED THAT THE PATIENT HAS NOT HAD THE VNS CHECKED FOR OVER A YEAR. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707751 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201848

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR