BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 4221731 · Received November 3, 2014

    Report

    Report Number
    1644487-2014-02907
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 VNS PATIENT¿S DEVICE WAS TESTED AND SYSTEM DIAGNOSTIC RESULTS REVEALED HIGH IMPEDANCE (DC DC ¿ 6). THE PATIENT WAS SENT FOR X-RAYS. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT DUE TO LEAD DISCONTINUITY. THE EXPLANTED GENERATOR AND LEAD WERE RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD WAS COMPLETED ON 12/15/2014. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL EXPOSED PORTION SHOW THAT THE COIL WAS EXPOSED TO SOME TYPE-OF ELECTRO-CAUTERY TOOL. SCANNING ELECTRON MICROSCOPY IMAGES OF THE NEGATIVE COIL ENDS AT THE FIRST AND SECOND PORTION OF THE LEAD SHOW THAT THE COIL WAS EXPOSED TO AND CUT USING SOME TYPE OF ELECTRO-CAUTERY TOOL AS INDICATED BY THE FUSED WIRES. REVIEW OF THE 'AS-RECEIVED' PHOTOGRAPH TAKEN PRIOR TO DECONTAMINATION SHOWS THE LEAD CONNECTORS REVERSED WITH THE MARKED CONNECTOR INSERTED IN THE NEGATIVE TERMINAL/CAVITY OF THE PULSE GENERATOR AND THE UNMARKED CONNECTOR INSERTED IN THE POSITIVE TERMINAL/CAVITY OF THE PULSE GENERATOR HEADER. NOTE THAT SINCE A PORTION OF THE LEAD (INCLUDING THE ELECTRODE HELICES) WAS NOT RETURNED FOR ANALYSIS, AN EVALUATION AND RESULTING COMMENTARY CANNOT BE MADE ON THAT PORTION OF THE LEAD. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTIONS. ANALYSIS OF THE GENERATOR WAS COMPLETED ON 12/16/2014. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS WERE FOUND WITH THE PULSE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702654 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 3690C

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR