BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3212978 · Received July 9, 2013

    Report

    Report Number
    1644487-2013-02050
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 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 CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    ONLY A PORTION OF THE LEAD WAS RETURNED FOR ANALYSIS WHICH DID NOT REVEAL ANY ANOMALIES. DEVICE FAILURE IS SUSPECTED IN THE LEAD PORTION NOT RETURNED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEAD REPLACEMENT ON (B)(6) 2013. IT WAS REPORTED THAT NO X-RAYS WERE PERFORMED AND NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE LEAD IS EXPECTED TO BE RETURNED TO MANUFACTURER FOR ANALYSIS, BUT HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT HIGH IMPEDANCE WAS SEEN DURING SYSTEM DIAGNOSTICS. THE DEVICE WAS DISABLED. THERE WAS NO KNOWN PATIENT MANIPULATION OR TRAUMA. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE.

    Description of Event or Problem · 1

    THE GENERATOR AND LEAD WERE RETURNED FOR ANALYSIS ON (B)(6) 2013. THE GENERATOR ANALYSIS WAS COMPLETED ON (B)(6) 2013. ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO ADVERSE FUNCTIONAL, MECHANICAL, OR VISUAL ISSUES IDENTIFIED WITH THE RETURNED GENERATOR. ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(6) 2013. NOTE THAT SINCE A SIGNIFICANT PORTION OF THE LEAD (INCLUDING THE ELECTRODE ARRAY) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313316 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 8601

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR