BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3133867 · Received May 29, 2013

    Report

    Report Number
    1644487-2013-01616
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REPORTER INDICATED THAT HIGH LEAD IMPEDANCE >8,000 OHMS WAS NOTED AT AN OFFICE VISIT WITH VNS DIAGNOSTICS TESTING ON (B)(6) 2013. THE VNS WAS DISABLED BUT THE MAGNET MODE SETTING WAS LEFT ON AT THE PARENT¿S REQUEST, AND THE PATIENT WAS REFERRED FOR SURGERY. X-RAYS WERE PERFORMED BUT WILL NOT BE SENT TO THE MANUFACTURER. THE PATIENT HAD NO TRAUMA AND DID NOT MANIPULATE THE VNS. THE PATIENT HAD VNS GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2013. THE EXPLANTED DEVICES WILL NOT BE RETURNED FROM THE HOSPITAL. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    REPORTER INDICATED THE LAST ACCEPTABLE DIAGNOSTICS WERE ON (B)(6) 2013 WITH 2095 OHMS. AN IMPLANT CARD WAS ALSO RECEIVED TO THE MANUFACTURER NOTING THAT DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS WITH THE NEW DEVICES AT THE (B)(6) 2013 SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235561 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 011314

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR