BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3112322 · Received May 14, 2013

    Report

    Report Number
    1644487-2013-01319
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 27, 2012
    Report Date
    April 16, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    AN IMPLANT CARD RECEIVED ON (B)(6) 2013 INDICATED THAT THIS VNS PATIENT UNDERWENT GENERATOR AND LEAD REVISION DUE TO BATTERY DEPLETION AND LEAD DISCONTINUITY ON (B)(6) 2013. REVIEW OF PROGRAMMING HISTORY SHOWED THAT A SYSTEM DIAGNOSTIC INDICATED HIGH IMPEDANCE ON (B)(6) 2012. FOLLOW-UP SHOWED THAT THE PATIENT WAS WELL-MANAGED WITH AN AWARENESS OF STIMULATION CYCLES. SINCE THE PATIENT AND PHYSICIAN WERE HAPPY WITH THE TREATMENT RESULTS, IT WAS NEVER INVESTIGATED MORE CLOSELY. THE EVENT WAS BELIEVED TO BE RELATED TO FIBROSIS. THE PLAN WAS TO WAIT UNTIL BATTERY DEPLETION AND THEN INVESTIGATE THE ELECTRODE, REPLACING IT AT THAT TIME. THERE WAS NO KNOWN MANIPULATION OR TRAUMA. DURING SURGERY, X RAYS WERE TAKEN, BUT NOTHING COULD BE SEEN. IN THEATRE, THE GENERATOR WAS REPLACED, BUT IMPEDANCE WAS STILL HIGH. THE SURGEON THEN DECIDED TO REPLACE THE LEAD AS WELL. THERE WAS A LARGE AMOUNT OF SCAR TISSUE, AND IT TOOK ALMOST THREE HOURS TO GET TO THE VAGUS NERVE. THE NEW LEAD WAS PLACED, BUT THERE WAS STILL A LOT OF SCAR TISSUE ON THE VAGUS NERVE, AND THE IMPEDANCE WAS STILL HIGH WITH THE NEW LEAD. THE SURGEON DECIDED THAT THE HIGH IMPEDANCE WAS DUE TO THE SCAR TISSUE AND THAT SINCE THE PATIENT WAS DOING WELL, NO ADDITIONAL INTERVENTION WOULD BE TAKEN. THE EXPLANTED LEAD WAS DISCARDED AND THE GENERATOR IS THE PATIENT'S POSSESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212244 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS INC 300-20 7910

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR