BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3070395 · Received April 22, 2013

    Report

    Report Number
    1644487-2013-01100
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    December 22, 2012
    Report Date
    March 25, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, CORRECTED DATA: THE CORRECT EVENT DATE FOR HIGH LEAD IMPEDANCE IS PROVIDED PER REVIEW OF INTERNAL GENERATOR DATA. 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

    REPORTER INDICATED THAT A LEAD DISCONTINUITY WAS NOTED DURING VNS GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013 FOR END OF SERVICE, AND A NEW LEAD AND GENERATOR WERE IMPLANTED. ADDITIONAL FOLLOW UP WITH THE REPORTER REVEALED THE LEAD DISCONTINUITY WAS FIRST NOTED ON (B)(6) 2013 WITH HIGH LEAD IMPEDANCE >10,000 OHMS WITH DIAGNOSTICS TESTING, BUT X-RAYS DID NOT VISUALIZE A LEAD FRACTURE. NO TRAUMA OR DEVICE MANIPULATION OCCURRED. THE X-RAYS WILL NOT BE RELEASED TO THE MANUFACTURER. THE EXPLANTED VNS LEAD AND GENERATOR WERE RETURNED ON (B)(4) 2013 AND ARE PENDING ANALYSIS.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED VNS GENERATOR AND LEAD. ANALYSIS OF THE GENERATOR DID NOT IDENTIFY ANY ANOMALIES THAT COULD AFFECT DEVICE FUNCTION. THE GENERATOR WAS AT A NEAR END OF SERVICE CONDITION (NEOS). REVIEW OF THE GENERATOR¿S INTERNAL MEMORY IDENTIFIED THAT AN IMPEDANCE CHANGE FROM 2353 OHMS TO 13059 OHMS OCCURRED ON (B)(6) 2012. ANALYSIS OF THE LEAD CONFIRMED A BREAK WAS IDENTIFIED IN THE POSITIVE COIL. SCANNING ELECTRON MICROSCOPY IMAGES OF THE POSITIVE COIL SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE BREAK LOCATION. HOWEVER, DUE TO MECHANICAL DISTORTION (SMOOTHED SURFACES), PITTING AND/OR SURFACE CONTAMINATION THE FRACTURE MECHANISM CANNOT BE DETERMINED. ALSO, A SINGLE BROKEN STRAND WAS NOTED IN THE NEGATIVE COIL. THE SILICONE TUBING OF THE POSITIVE COIL IS ABRADED OPEN. DRY BODY FLUIDS WERE NOTED INSIDE THE INNER SILICONE TUBING. NOTE THAT SINCE THE ELECTRODE ARRAY PORTION 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171153 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 200936

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR