BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3072717 · Received April 23, 2013

    Report

    Report Number
    1644487-2013-01122
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INADVERTENTLY DID NOT REPORT THE PATIENT'S AGE AT THE TIME OF FINDING THE HIGH IMPEDANCE. THE INITIAL REPORT INADVERTENTLY DID NOT REPORT THE DATE THAT THE HIGH IMPEDANCE WAS FOUND. THE INITIAL REPORT INADVERTENTLY REPORTED THE INCORRECT DATE OF THE DIAGNOSTIC DATA. REVIEW OF DEVICE HISTORY RECORDS PERFORMED. REVIEW OF LEAD DEVICE HISTORY RECORDS CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A NEUROLOGIST REPORTED TO OUR CONSULTANT THAT THEY HAD VNS PATIENT WHO HAD HIGH LEAD IMPEDANCE AND WAS STILL SEIZURE FREE. THEY MADE THE CHOICE TO LEAVE THEIR DEVICE ON. THEY WERE NOT SURE HOW THIS HAPPENED, BUT WERE DEBATING WHAT HE WAS GOING TO DO (REPLACE OR NOT). NO REPORT OF ANY PATIENT FALL OR INJURY PRIOR TO THEIR HIGH LEAD IMPEDANCE. NO SURGERY IS PLANNED AT THIS TIME. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT.

    Description of Event or Problem · 1

    A COPY OF THE PHYSICIAN'S PROGRAMMING DATA WAS RECEIVED BY THE MANUFACTURER, BUT IT DID NOT CONTAIN DIAGNOSTICS FOR (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED FROM THE NURSE AT THE PHYSICIAN'S OFFICE REVEALED THAT NO X-RAYS WERE TAKEN AND INTERVENTION IS STILL NOT PLANNED. NO SURGERY IS PLANNED AT THIS TIME. THE LAST DIAGNOSTICS WERE PERFORMED IN (B)(6) 2012 AT WHICH TIME THEY WERE WITHIN NORMAL LIMITS. THEY WERE NOT AWARE OF ANY PATIENT TRAUMA OR INJURY THAT MAY HAVE CONTRIBUTED TO THE HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175403 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 7036

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR