BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 3881476 · Received June 18, 2014

    Report

    Report Number
    1644487-2014-01524
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DEVICE DIAGNOSTICS SHOWED LOW IMPEDANCE. THE PATIENT WAS REFERRED FOR LEAD REPLACEMENT. THERE WAS NO TRAUMA THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE LOW IMPEDANCE. THE GENERATOR WAS NOT PROGRAMMED OFF AFTER OBSERVING THE HIGH IMPEDANCE BECAUSE THE PATIENT WAS EXPERIENCING AN INCREASE IN SEIZURES. THE PHYSICIAN REPORTED THAT THE INCREASE IN SEIZURES WAS RELATED TO THE LOW IMPEDANCE. X-RAYS WERE NOT PERFORMED. THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT. THE EXPLANTED DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    ANALYSIS OF THE GENERATOR WAS COMPLETED ON 07/21/2014. A COMPREHENSIVE AUTOMATED ELECTRICAL EVALUATION SHOWED THAT THE PULSE GENERATOR PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE PULSE GENERATOR. IT WAS REPORTED THAT THE PATIENT IS DOING BETTER SINCE VNS REPLACEMENT. REVIEW OF THE GENERATOR DECODER IDENTIFIED THAT THE LOW IMPEDANCE WAS FIRST DETECTED ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR AND LEAD WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE LEAD ASSEMBLY HAS DRIED REMNANTS OF WHAT APPEAR TO HAVE ONCE BEEN BODY FLUIDS INSIDE THE INNER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE END OF THE RETURNED LEAD PORTION. OTHER THAN TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN 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. ANALYSIS OF THE RETURNED GENERATOR IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357830 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 4557C

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention