BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2881306 · Received December 20, 2012

    Report

    Report Number
    1644487-2012-03414
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION CAUSED EVENT BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A NURSE IN THE UNITED KINGDOM REPORTED THAT THEY HAD A PATIENT WHO HAD BEEN IMPLANTED WITH THEIR VNS DEVICE (B)(6) 2010 AND THEY HAD HIGH LEAD IMPEDANCE, SYSTEM DIAGNOSTICS 10000 OHMS. X-RAYS WERE ORDERED AND THE DEVICE WAS SWITCHED OFF. THE PATIENT HAS BEEN REFERRED TO NEUROSURGERY. X-RAYS WILL NOT BE SENT TO THE MANUFACTURE FOR REVIEW. THE PATIENT WILL HAVE FULL REVISION SURGERY PERFORMED. NO DATE HAS BEEN SET AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 201156

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR