BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2883304 · Received December 21, 2012

    Report

    Report Number
    1644487-2012-03346
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    July 11, 2012
    Report Date
    December 3, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2012, THIS VNS PATIENT UNDERWENT GENERATOR DUE TO BATTERY NEOS=YES AND LEAD REVISION FOR AN UNKNOWN REASON. THE EXPLANTED DEVICES WERE RETURNED, AND PRODUCT ANALYSIS WAS PERFORMED. ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. PRODUCT ANALYSIS WAS APPROVED ON (B)(6) 2012. IT WAS REPORTED THAT PATIENT'S GENERATOR WAS EXPLANTED DUE TO NEOS=YES. PRODUCT WAS RETURNED, AND PA WAS PERFORMED. PA FOUND THAT THE DEVICE WAS ENABLED. A REVIEW OF THE AS-RECEIVED DECODER SPREADSHEET REVEALS THAT HIGH IMPEDANCE WAS SEEN. THE GENERATOR'S MEMORY SHOWED IT TO BE PROGRAMMED OFF (OUTPUT CURRENT: 0.00), 20HZ (SIGNAL FREQUENCY), AND 500 USEC (PULSE WIDTH). HIGH IMPEDANCE WAS NOTED ON (B)(6) 2012. IMPEDANCE CHANGED FROM 7801 OHMS TO 9952 OHMS. PRODUCT ANALYSIS OF THE PATIENT'S LEAD WAS ALSO COMPLETED. NOTE THAT A PORTION OF THE LEAD ASSEMBLY (BODY) INCLUDING THE ELECTRODES WAS NOT RETURNED FOR ANALYSIS; THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS THE CONNECTOR PIN QUADFILAR COIL APPEARED TO BE BROKEN AT TWO LOCATIONS. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE CONNECTOR PIN QUADFILAR COIL BREAK AND IDENTIFIED THE AREA AS BEING THIN AND HAVING EXTENSIVE PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE AND EVIDENCE OF ELECTRO-ETCHING ON THE SURFACE. SCANNING ELECTRON MICROSCOPY WAS PERFORMED ON THE CONNECTOR PIN QUADFILAR COIL SECOND BREAK AND IDENTIFIED THE AREA AS BEING MECHANICALLY DAMAGED AND PITTED WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. IT IS BELIEVED THAT STIMULATION WAS PRESENT FOR A CERTAIN PERIOD OF TIME AS EVIDENCED BY THE PRESENCE OF METAL PITTING. LOW MAGNIFICATION SEM ANALYSIS OF THE QUADFILAR COIL SHOWS CHARACTERISTICS TYPICAL OF A LEAD DISCONTINUITY. ABRADED OPENINGS IN THE OUTER AND INNER TUBING WERE ALSO LOCATED IN ADDITION TO SLICE MARKS. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITY, THE CONDITION OF THE RETURNED LEAD PORTION IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER 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 OTHER DISCONTINUITIES IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 8664

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR