BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3073585 · Received April 23, 2013

    Report

    Report Number
    1644487-2013-01128
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    August 10, 2007
    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
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED FROM THE PHYSICIAN ON (B)(6) 2013 STATING THAT THE VNS GENERATOR WAS NOT TURNED OFF AND NO X-RAYS WERE PERFORMED. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED OT THE EVENT. NO INTERVENTIONS WERE TAKEN OR PLANNED 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) 2007 OUTPUT STATUS = OK, LEAD IMPEDANCE = OK, DCDC=7, EOS= NO. ON (B)(6) 2004 DIAGNOSTICS SHOWED OUTPUT STATUS = OK, LEAD IMPEDANCE = OK, DCDC=3, EOS= NO. THE HIGH IMPEDANCE CONTINUED TILL (B)(6) 2008 WHICH SHOWED OUTPUT STATUS = OK, LEAD IMPEDANCE = OK, DCDC=7, EOS= NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174789 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-30 3862

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR