BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3042434 · Received April 9, 2013

    Report

    Report Number
    1644487-2013-00954
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR OR LEAD PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A GENERATOR AND LEAD REPLACEMENT AND HAS BEEN TURNED BACK ON. PRODUCT RETURN ATTEMPTS HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE ON SYSTEMS AND NORMAL MODE DIAGNOSTICS. THE PHYSICIAN DISABLED THE PATIENT AT A LATER APPOINTMENT. PATIENT DENIES ANY MANIPULATION OR TRAUMA. THE PATIENT HAS REPORTED PAIN IN HER ARM AND NECK FOR 3 WEEKS PRIOR TO THE HIGH IMPEDANCE BEING VISUALIZED. IT IS UNKNOWN IF THE PAIN IS OCCURRING WITH STIMULATION OR IF IT IS RELATED TO THE HIGH IMPEDANCE. THE PATIENT WAS REFERRED FOR SURGERY. SURGERY IS LIKELY BUT HAS NOT OCCURRED TO DATE. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE PHYSICIAN RESPONDED TO ATTEMPTS BUT DID NOT ADDRESS THE QUESTION AND ONLY PROVIDED SOME PROGRAMMING HISTORY. REVIEW OF MANUFACTURING RECORDS CONFIRMED THERE WERE NO UNRESOLVED NON CONFORMANCES FOUND WITH THE GENERATOR OR LEAD PRIOR TO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145198 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-30 200241

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR