BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3081770 · Received April 29, 2013

    Report

    Report Number
    1644487-2013-01188
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 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
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED BUT DID NOT LEAD TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A POTENTIAL LEAD BREAK WAS REPORTED DUE TO HIGH IMPEDANCE. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. REVIEW OF PROGRAMMING HISTORY SHOWS THAT THE DEVICE WAS INTERROGATED ON (B)(6) 2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD A GENERAL ANESTHETIC ON (B)(6) 2012 FOR A PROCEDURE. WHEN THE HIGH IMPEDANCE WAS SEEN ON (B)(6) 2013 DURING A SYSTEM DIAGNOSTIC, THE DEVICE WAS DISABLED. X-RAYS DID NOT IDENTIFY ANY BREAK OR PIN ISSUE FROM THE AVAILABLE VIEW, BUT THE X-RAYS WILL NOT BE PROVIDED FOR REVIEW. THE PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013, BUT THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184556 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200399

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR