BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3073172 · Received April 23, 2013

    Report

    Report Number
    1644487-2013-01125
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    February 14, 2012
    Report Date
    March 25, 2013
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT WILL UNDERGO SURGERY TO EXPLANT HIS DEVICE. THE PATIENT¿S DEVICE WILL NOT BE REPLACED. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    WHILE REVIEWING THE PATIENT'S VNS GENERATOR PROGRAMMING HISTORY, HIGH LEAD IMPEDANCE WAS NOTED ON A DIAGNOSTIC HISTORY ON (B)(6) 2012. THE PREVIOUS DIAGNOSTICS PERFORMED ON (B)(6) 2011 WERE WITHIN NORMAL LIMITS AND SHOWED OUTPUT STATUS = OK, LEAD IMPEDANCE = OK, 2424 OHMS, INTENSIFIED FOLLOW-UP INDICATOR = YES. ON (B)(6) 2012 DIAGNOSTICS SHOWED OUTPUT STATUS = LOW, LEAD IMPEDANCE = HIGH, >=10,000 OHMS, NEOS (NEAR END OF SERVICE) = YES ACCORDING TO THE PHYSICIAN THE PATIENT'S VNS GENERATOR WAS TURNED OFF ON (B)(6) 2012 FOLLOWING THE NOTED HIGH IMPEDANCE. X-RAYS WERE TAKEN BUT WAS NOT RECEIVED TO THE MANUFACTURER FOR REVIEW TO DATE. A REVIEW BY THE PHYSICIAN OF THE X-RAYS WAS RECEIVED WHICH NOTED A LEAD FRACTURE. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH LEAD IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175603 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200631

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR