BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2915693 · Received January 15, 2013

    Report

    Report Number
    1644487-2013-00092
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 21, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONRTIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED THAT A VNS PATIENT WOULD BE UNDERGOING LEAD REVISION FOR AN UNKNOWN REASON. CLINIC NOTES WERE RECEIVED ON (B)(6) 2012. NOTES DATED (B)(6) 2012 INDICATED THAT THE PATIENT'S SEIZURES SEEMED TO STOP AFTER VNS PLACEMENT. THE PATIENT'S DEVICE WAS INTERROGATED HIGH IMPEDANCE WAS NOTED. WHILE THE PATIENT REMAINED SEIZURE-FREE, THE INTERROGATION INDICATED LEAD DIFFICULTIES (8668 OHMS), AND THE PATIENT WAS BEING REFERRED FOR REVISION. NOTES DATED (B)(6) 2012 INDICATED THAT THE PATIENT'S SEIZURE WERE INTRACTABLE IN THE PAST AND WERE DIFFICULT TO CONTROL PRIOR TO VNS. THE DEVICE WAS INTERROGATED, AND A LEAD CHECK WAS OBTAINED WITHOUT DIFFICULTIES. SETTINGS WERE PROVIDED. ON (B)(6) 2012, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT WAS SEIZURE FREE SHORTLY AFTER HE WAS IMPLANTED. X-RAYS WERE TAKEN BUT WERE NOT AVAILABLE. THE PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT'S GENERATOR WAS DISCARDED AFTER SURGERY. NO INFORMATION WAS PROVIDED REGARDING THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22134 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 2004

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR