BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3885017 · Received June 19, 2014

    Report

    Report Number
    1644487-2014-01547
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    August 21, 2013
    Report Date
    May 21, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ADVERSE EVENT, CORRECTED DATA: INITIAL REPORT INADVERTENTLY REPORTED AN ADVERSE EVENT. DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: INITIAL REPORT INADVERTENTLY REPORTED AN ADVERSE EVENT THAT DID NOT OCCUR. TYPE OF REPORTABLE EVENT, CORRECTED DATA: INITIAL REPORT INADVERTENTLY REPORTED A SERIOUS INJURY. EVALUATION CODES, CONCLUSIONS, CORRECTED DATA: (B)(4).

    Description of Event or Problem · 1

    FURTHER REVIEW OF THE CLINIC NOTES DATED (B)(6) 2013 INDICATE THAT THE PHYSICIAN HAD DOCUMENTED ¿IF (THE PATIENT) IS STARTING TO HAVE MORE SEIZURES¿¿, NOT THAT THE PATIENT ACTUALLY WAS STARTING TO HAVE MORE SEIZURES. THEREFORE THE EVENT OF AN INCREASE IN SEIZURES WAS INADVERTENTLY REPORTED AS AN ADVERSE EVENT.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 NOTE THAT THE PATIENT IS STARTING TO HAVE MORE SEIZURES. IT WAS NOTED THAT BATTERY LIFE CALCULATIONS SHOWED 3.35 YEARS. CLINIC NOTES DATED (B)(6) 2013 NOTE THAT THE PATIENT IS HAVING NO SEIZURES. IT IS UNKNOWN IF THE INCREASE IN SEIZURES WAS ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361935 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 012565

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR