BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3781333 · Received April 30, 2014

    Report

    Report Number
    1644487-2014-01136
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. 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 DURING AN OFFICE VISIT ON (B)(6) 2014 AND DIAGNOSTIC RESULTS REVEALED HIGH LEAD IMPEDANCE (DC DC ¿ 7). THE DEVICE WAS NOT PROGRAMMED OFF FOLLOWING THE HIGH IMPEDANCE OBSERVATION. X-RAYS WERE NOT TAKEN. THE PATIENT DID NOT REPORT ANY INJURIES. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2014. PRE-OPERATIVE DIAGNOSTICS SHOWED HIGH IMPEDANCE SO THE GENERATOR WAS REPLACED. DIAGNOSTIC RESULTS WITH THE REPLACEMENT GENERATOR AND EXISTING LEAD SHOWED HIGH IMPEDANCE. THE SURGEON REPORTED THAT THERE WAS FIBROSIS IN THE PATIENT¿S NECK; HOWEVER, THE PATIENT¿S NECK WAS NEVER OPENED. THE PATIENT¿S PARENT DID NOT WANT TO PROCEED WITH LEAD REPLACEMENT AND ELECTED TO WAIT TO SEE IF THE PATIENT¿S SEIZURES RETURN. THE SURGEON REMOVED THE REPLACEMENT GENERATOR AND A PORTION OF THE PATIENT¿S LEAD WITHOUT REPLACEMENT. THE EXPLANTED GENERATOR AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    THE LEAD ASSEMBLY HAS DRIED REMNANTS OF WHAT APPEAR TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE INNER AND OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENING AND THE CUT END OF THE RETURNED LEAD PORTION. INCISIONS IN THE SILICONE TUBING OF THE LEAD WERE NECESSARY TO PERFORM PROPER INSPECTION OF THE LEAD COILS. AN ABRADED OPENING WAS NOTED ON THE OUTER SILICONE TUBING. THE REPORTED HIGH IMPEDANCE ALLEGATIONS WERE NOT VERIFIED WITHIN THE RETURNED LEAD PORTION. 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 THE ABOVE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. ANALYSIS OF THE GENERATOR CONCLUDED THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259361 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 6948

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR