BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 1181368 · Received September 23, 2008

    Report

    Report Number
    1644487-2008-02295
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 26, 2008
    Report Date
    March 17, 2017
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED DIAGNOSTIC RESULTS CHARACTERISTIC OF A LEAD BREAK DURING A ROUTINE OFFICE VISIT. THE TREATING PHYSICIAN REQUESTED X-RAYS TO BE TAKEN DUE TO PAIN THE PATIENT WAS EXPERIENCING AT THE GENERATOR SITE DURING STIMULATION. DURING THE PHYSICIAN'S X-RAY ASSESSMENT, A LEAD BREAK WAS IDENTIFIED CLOSE TO THE GENERATOR THEREFORE, THE PHYSICIAN PROGRAMMED THE PATIENT'S DEVICE OFF. THE PHYSICIAN DID NOT RECALL THE PATIENT REPORTING ANY MANIPULATION OR TRAUMA THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE PATIENT'S DEVICE WILL BE REPLACED HOWEVER NO SURGERY DATE IS CURRENTLY SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LYJ CYBERONICS, INC. 300-20 19227C

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male