BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2760332 · Received September 26, 2012

    Report

    Report Number
    1644487-2012-02438
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 29, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    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 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

    REPORTER INDICATED A LEAD FRACTURE WAS SEEN DURING SURGERY TO EXPLANT THE VNS DEVICE. THE VNS WAS BEING EXPLANTED AS THE PATIENT NEEDED AN MRI PROCEDURE PERFORMED, AND LEAD INTEGRITY COULD NOT BE ASSESSED AS THE GENERATOR WAS AT END OF SERVICE AND WAS UNABLE TO BE INTERROGATED. THE GENERATOR WAS EXPLANTED AND THE LEAD WAS CUT, WITH THE ELECTRODE PORTION REMAINING IN THE PATIENT. A BATTERY LIFE ESTIMATE PERFORMED BY THE MANUFACTURER RESULTED IN -2 YEARS REMAINING, INDICATING GENERATOR END OF SERVICE IS LIKELY. ATTEMPTS FOR ADDITIONAL INFORMATION AND RETURN OF THE EXPLANTED GENERATOR AND LEAD REMNANT ARE IN PROGRESS.

    Description of Event or Problem · 1

    ANALYSIS OF THE LEAD REMNANT RETURNED WAS COMPLETED. THE LEAD'S ELECTRODES WERE NOT RETURNED FOR EVALUATION. A POSITIVE MATCH BETWEEN THE INITIAL PORTION RECEIVED AND THE SECOND ADDITIONAL PORTION OF THE LEAD RETURNED CANNOT BE MADE. A POSITIVE DISTINCTION BETWEEN THE POSITIVE AND THE NEGATIVE LEAD COIL CANNOT BE MADE. THE LEAD ASSEMBLY IS CUT AT APPROXIMATELY 21.3CM PRIOR TO THE ELECTRODE BIFURCATION AND AT APPROXIMATELY 2CM PAST THE ELECTRODE BIFURCATION. ABRASIONS MOST LIKELY CAUSED BY THE PRESENCE OF A TIE-DOWN WERE IDENTIFIED AT APPROXIMATELY 1CM AND 4.8CM PRIOR TO THE ELECTRODE BIFURCATION. A CUT OPENING WAS IDENTIFIED ON THE OUTER SILICONE TUBING AT APPROXIMATELY 4.6CM PRIOR TO THE ELECTRODE BIFURCATION REACHING THE INNER SILICONE TUBING AND COIL OF ONE OF THE LEAD COILS AND CUTTING THE COIL. THE INNER SILICONE TUBING OF BOTH LEAD COILS IS ABRADED OPEN AT THIS LOCATION. THE LEAD ASSEMBLY HAS REMNANTS OF WHAT APPEARS TO BE DRY BODY FLUIDS INSIDE THE INNER AND THE OUTER SILICONE TUBING. NO OBVIOUS POINT OF ENTRANCE WAS NOTED OTHER THAN THE IDENTIFIED TUBING OPENINGS AND THE END OF THE RETURNED LEAD PORTION. NO OBVIOUS LEAD DISCONTINUITIES WERE NOTED IN THE 2ND RETURNED LEAD PORTION.

    Description of Event or Problem · 1

    THE EXPLANTED VNS LEAD AND GENERATOR WERE RETURNED FOR ANALYSIS. NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. NOTE THAT SINCE A 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 TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. ANALYSIS OF THE GENERATOR CONFIRMED THE GENERATOR WAS AT NORMAL END OF SERVICE. THE DEPLETION WAS AN EXPECTED EVENT AS DETERMINED BY A BATTERY LIFE ESTIMATE (0 YEARS REMAINING) AND BATTERY VOLTAGE MEASUREMENT. THE MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THERE WAS NO CONDITION NOTED DURING THE PRODUCT ANALYSIS EVALUATION THAT WOULD SUGGEST ANY ANOMALY WITH THE DEVICE.

    Description of Event or Problem · 1

    REPORTER INDICATED THE REMNANT PORTION OF THE PATIENT'S VNS LEAD WAS EXPLANTED ON (B)(6) 2012. A NEW VNS GENERATOR AND LEAD WAS IMPLANTED ON (B)(6) 2012. DIAGNOSTICS WITH THE NEW DEVICES WERE WITHIN NORMAL LIMITS. THE LEAD ELECTRODE REMNANTS WERE RETURNED FOR ANALYSIS ON (B)(4) 2012 AND RESULTS ARE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 1409

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR