BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3150259 · Received June 6, 2013

    Report

    Report Number
    1644487-2013-01696
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    January 1, 2009
    Report Date
    May 10, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE FOLLOW-UP MFR. REPORT #02 INADVERTENTLY REPORTED THIS FIELD INCORRECTLY. THIS HAS BEEN CORRECTED IN THIS REPORT. THE REPLACEMENT DEVICE BEING EXPLANTED DUE TO LACK OF EFFICACY IS NOT RELATED TO THE HIGH IMPEDANCE EVENT AND SHOULD NOT HAVE BEEN REPORTED ON THE PREVIOUS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WAS SEEN ON (B)(6) AND THE THERAPY WAS NOT WORKING WELL ON THIS PATIENT, BECAUSE HE WAS NOT A GOOD RESPONDER. THE DEVICE WAS REMOVED, NOT TURNED OFF, AND WAS ANT END OF SERVICE WITH HIGH IMPEDANCE. THE PHYSICIAN LET THE BATTERY DIE AND NO BREAK WAS NOTED. THE DEVICE WILL NOT BE RETURNED. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013 THAT THE PHYSICIAN HAS NOT HAD X-RAYS PERFORMED ON THE PATIENT.

    Description of Event or Problem · 1

    AN IMPLANT CARD RECEIVED ON (B)(4) 2010 REPORTED THAT A VNS PATIENT UNDERWENT A RE-IMPLANT OF M102 SN# (B)(4) REPLACED BY M102 SN# (B)(4) AND M302-20 SN# (B)(4) REPLACED BY M302-20 SN# (B)(4). RE-IMPLANT SURGERY TOOK PLACE ON (B)(6) 2010 AT (B)(6). NO REASON FOR REPLACEMENT WAS MARKED ON THE IMPLANT CARD. LEAD IMPEDANCE WAS NOT INDICATED. FURTHER INVESTIGATION OF INTERNAL PROGRAMMING HISTORY REVEALED THAT THE PATIENT HAD HIGH LEAD IMPEDANCE ON (B)(6) 2009 THROUGH (B)(6) 2010. ACTUAL DATE OF EVENT UNKNOWN. GOOD FAITH ATTEMPTS ARE UNDERWAY FOR FURTHER DETAILS ABOUT THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIGH IMPEDANCE WAS RESOLVED WITH VNS REPLACEMENT THAT OCCURRED ON (B)(6) 2010. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251110 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1012

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR