BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2974809 · Received February 22, 2013

    Report

    Report Number
    1644487-2013-00488
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 26, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    ANALYSIS OF THE VNS GENERATOR WAS COMPLETED. AN END-OF-SERVICE WARNING MESSAGE WAS VERIFIED IN THE PA LAB AND FOUND TO BE ASSOCIATED WITH THE PULSE DISABLED BY THE PULSE GENERATOR. WITH THE PULSE GENERATOR CASE REMOVED AND THE BATTERY STILL ATTACHED TO THE PCB, THE BATTERY MEASURED 2.005 VOLTS, INDICATING A DEPLETED BATTERY. THE DATA IN THE DIAGACCUMCONSUMED MEMORY LOCATIONS REVEALED THAT 100.092% OF THE BATTERY HAD BEEN CONSUMED. THE POST BURN-IN ELECTRICAL TEST RESULTS SHOWED THAT THE PULSE GENERATOR MODULE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    REPORTER INDICATED HIGH LEAD IMPEDANCE WAS NOTED WHEN A NEW VNS GENERATOR WAS ATTACHED TO THE RESIDENT LEAD DURING A PATIENT'S VNS GENERATOR REPLACEMENT SURGERY ON (B)(6) 2013. GENERATOR DIAGNOSTICS WITH THE NEW VNS GENERATOR WERE WITHIN NORMAL LIMITS. HIGH LEAD IMPEDANCE WITH EOS = YES WAS PREVIOUSLY RECEIVED ON (B)(6) 2012. THE PATIENT HAD NO KNOWN TRAUMA AND DID NOT MANIPULATE THE VNS. THE PATIENT'S SEIZURES WERE WELL-CONTROLLED AND HAD BEEN SEEN IRREGULARLY IN THE CLINIC. NO X-RAYS WERE TAKEN PRIOR TO THE SURGERY. THE EXPLANTED LEAD AND GENERATOR WERE RETURNED FOR ANALYSIS. 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 LOCATIONS. ALSO, IMAGES OF FOUR STRAND SEGMENTS SHOW THAT PITTING OR ELECTRO-ETCHING CONDITIONS HAVE OCCURRED AT THE BREAK LOCATIONS. THE COIL SHOWS MECHANICAL DISTORTION (SMOOTHED SURFACES) ON AT LEAST ONE STRAND OF THE QUADFILAR COIL. DUE TO METAL DISSOLUTION AND OR SURFACE CONTAMINATION THE FRACTURE MECHANISM CANNOT BE DETERMINED. ABRADED OPENINGS OF BOTH INNER TUBES NEAR THE BREAK LOCATION WERE OBSERVED. OTHER THAN THE MENTIONED OBSERVATIONS AND TYPICAL WEAR AND EXPLANT RELATED OBSERVATIONS, NO OTHER ANOMALIES WERE IDENTIFIED IN THE RETURNED LEAD PORTION. ANALYSIS OF THE GENERATOR IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78372 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 2351

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR