BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 4201101 · Received October 27, 2014

    Report

    Report Number
    1644487-2014-02828
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SURGERY DEVICE DIAGNOSTICS SHOWED HIGH IMPEDANCE WITH THE NEW GENERATOR ATTACHED TO THE EXISTING LEAD. THE GENERATOR WAS TESTED WITH THE TEST RESISTER WHICH SHOWED THE GENERATOR WAS WITHIN NORMAL LIMITS. THE SURGEON THEN DISSECTED THE LEAD COILS OFF OF THE NERVE AND PLACED A NEW LEAD. AN IMPLANT CARD WAS RECEIVED CONFIRMING THAT BOTH THE GENERATOR AND LEAD WERE REPLACED AND THAT LEAD IMPEDANCE WITH THE NEW SYSTEM WAS WITHIN NORMAL LIMITS. THE EXPLANTED LEAD WAS RECEIVED FOR ANALYSIS. ANALYSIS OF THE LEAD WAS COMPLETED ON (B)(4) 2014. A BREAK WAS IDENTIFIED IN THE POSITIVE COIL. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL BROKEN ENDS SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE BREAK LOCATION. HOWEVER, DUE TO METAL DISSOLUTION AND SURFACE CONTAMINATION THE FRACTURE MECHANISM CANNOT BE DETERMINED. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS RESULTED IN HIGH IMPEDANCE (DC DC CODE - 7). THE PATIENT WAS REFERRED TO NEUROSURGERY. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682444 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1080

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR