BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2811463 · Received October 31, 2012

    Report

    Report Number
    1644487-2012-02507
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    July 26, 2012
    Report Date
    October 4, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    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

    ON (B)(6) 2012, IT WAS REPORTED THAT THIS PATIENT'S LEAD WAS REPLACED DURING HER GENERATOR REVISION SURGERY ON (B)(6) 2012, BECAUSE, A LEAD DISCONTINUITY WAS NOTED IN ONE OF THE LEADS DURING MOBILIZATION OF THE PULSE GENERATOR THE MOST RECENT DIAGNOSTIC RESULTS AVAILABLE WERE FROM (B)(6) 2012. IT WAS UNKNOWN IF THE LEAD WAS DISCONTINUITY OCCURRED DURING SURGERY OR PRIOR TO SURGERY. IT WAS STATED THAT THE PATIENT'S GENERATOR WAS INITIALLY REVISED BECAUSE THE PATIENT REPORTED FEELING MORE SEIZURES COMING ON. THIS REPORT OF INCREASED SEIZURES AND GENERATOR REVISION IS CAPTURED IN MFR REPORT #1644487-2012-01846. THE EXPLANTED LEAD WAS RETURNED ON (B)(4) 2012. AN ANALYSIS WAS PERFORMED ON THE RETURNED LEAD PORTION. THE MAJORITY OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS AND THEREFORE, A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OBVIOUS ANOMALIES WERE NOTED. THE SETSCREW MARKS FOUND ON THE LEAD CONNECTOR PIN PROVIDE EVIDENCE THAT, AT ONE POINT IN TIME, A GOOD MECHANICAL AND ELECTRICAL CONNECTION WAS PRESENT. CONTINUITY CHECKS OF THE RETURNED LEAD PORTION WERE PERFORMED, DURING THE VISUAL ANALYSIS, WITH NO DISCONTINUITIES IDENTIFIED. BASED ON THE FINDINGS IN THE PRODUCT ANALYSIS LAB, THERE IS NO EVIDENCE TO SUGGEST AN ANOMALY WITH THE RETURNED PORTION OF THE DEVICE. NOTE THAT SINCE THE MAJORITY OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODE ARRAY SECTION WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 1129

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR