BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3120322 · Received May 20, 2013

    Report

    Report Number
    1644487-2013-01360
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT HIGH IMPEDANCE WAS SEEN DURING DIAGNOSTICS. THE PATIENT¿S DEVICE WAS PROGRAMMED OFF FOR A SPINAL SURGERY, AND UPON PROGRAMMING THE DEVICE WAS ON, DIAGNOSTICS SHOWED HIGH IMPEDANCE. THE PATIENT¿S SETTINGS WERE PROVIDED, BUT THE DEVICE WAS DISABLED AFTER THE HIGH IMPEDANCE WAS SEEN. THE PATIENT HAD NOT LEFT THE HOSPITAL NOR HAD ANY OTHER TRAUMA. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    A RESPONSE FROM THE PHYSICIAN SHOWED THAT IMPEDANCE WAS 4868 OHMS ON (B)(6) 2013 AT 8:52 AM. IT IS UNKNOWN IF X-RAYS WILL BE TAKEN. SURGERY IS STILL LIKELY BUT HAS NOT TAKEN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222258 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1169

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR