BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3001446 · Received March 13, 2013

    Report

    Report Number
    1644487-2013-00683
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    December 1, 2012
    Report Date
    February 14, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THE SUPPLEMENTAL REPORT #4 INADVERTENTLY DID NOT CHANGE THE PATIENT'S AGE AT THE TIME OF THE INCREASED SEIZURES FIRST BEGAN. THE SUPPLEMENTAL REPORT #4 INADVERTENTLY DID NOT CHANGE THE APPROXIMATE ONSET OF THE INCREASED SEIZURES FIRST BEGAN PER THE SURGEON.

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED AND MAY HAVE CONTRIBUTED TO AN INCREASE IN SEIZURES.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: THE DATA IN SUPPLEMENTAL #3 WAS INADVERTENTLY NOT INCLUDED IN SUPPLEMENTAL REPORT #2, AS THE INFORMATION WAS ATTAINED ON (B)(6) 2013 PRIOR TO SUPPLEMENTAL REPORT #2 BEING SUBMITTED. DATE RECEIVED BY MANUFACTURER, CORRECTED DATA: THE SUPPLEMENTAL REPORTS #2 AND #3 INADVERTENTLY HAD THE INCORRECT THE INFORMATION WAS RECEIVED BY THE MANUFACTURER. THE DATES FOR REPORT #2 AND #3 SHOULD HAVE READ AS (B)(6) 2013, RESPECTIVELY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE SURGEON REPORTING THAT THE SCARRING AROUND THE ELECTRODE AND VAGUS NERVE AS DUE TO NORMAL PRESENCE OF THE DEVICE. THE PATIENT BEGAN EXPERIENCING INCREASED SEIZURES BELOW PRE-VNS BASELINE ABOUT WHAT APPEARS TO BE ABOUT TWO MONTHS PRIOR. THE PATIENT WAS THEREFORE REFERRED FOR REVISION. NO CAUSAL OR CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDE THE ONSET OF THE INCREASED SEIZURES. ONLY ONE SEIZURE TYPE INCREASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED PROPHYLACTIC GENERATOR REPLACEMENT ON (B)(6) 2013 THAT HIGH LEAD IMPEDANCE WAS OBSERVED IN THE OPERATING ROOM, SO THE LEAD WAS REPLACED AS WELL. FOLLOW-UP WITH THE SURGEON'S OFFICE THAT PER THE OPERATIVE NOTES, THE SURGEON OBSERVED A DEFECT FOUND IN THE COATING OF THE ELECTRODE DURING SURGERY. DETAILS WERE NOT PROVIDED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE EXPLANT FACILITY DOES NOT RETURN EXPLANTED PRODUCTS TO THE MANUFACTURER FOR ANALYSIS, SO THE EXPLANTED PRODUCTS HAVE NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON REPORTING THAT THE PATIENT WAS NOT RECEIVING STIMULATION FOR SOME TIME DUE TO THE LEAD BREAK. THE OPERATIVE NOTES INDICATE THAT A "DEFECT WAS SEEN IN THE PLASTIC COATING OF THE VNS ELECTRODE WITHIN THE CHEST CAVITY." THE PRE-OPERATIVE DIAGNOSIS STATES "MALFUNCTION DEVICE." ADDITIONALLY, "INSPECTION OF THE FLUID WITHIN THE INSULATION OF THE ELECTRODE AND UPON CLOSER INSPECTION, A SMALL DEFECT OR LACERATION OF THE PLASTIC SHEATH WAS OBSERVED. BASED ON THIS, DECISION WAS TO OPEN UP THE CERVICAL WOUND AND REPLACE THE ELECTRODE." DURING THE SURGERY, THE PREVIOUS VNS ELECTRODE WAS DISSECTED FROM THE SURFACE OF THE VAGUS NERVE AND SCAR TISSUE WAS DISSECTED "ROSTRALLY AND CAUDALLY FORM THE NERVE SURFACE TO PROVIDE FOR ADEQUATE EXPOSURE FOR A NEW ELECTRODE PLACEMENT." THE GENERATOR AND LEAD WERE REPLACED AND GOOD LEAD IMPEDANCE RESULTED UPON DIAGNOSTICS. THE HIGH LEAD IMPEDANCE WAS NOT OBSERVED PRIOR TO SURGERY, AND DCDC=7 WAS NOT OBSERVED UPON DIAGNOSTICS IN THE OPERATING ROOM. THE DEVICE WAS NOT TURNED OFF PRIOR TO SURGERY. THERE AN OUTER TUBING DEFECT PER THE SURGEON WHERE THERE WAS BLOOD TRACKING INSIDE THE TUBING. THE PATIENT EXHIBITED DECREASING EFFICACY OF STIMULATION ASSOCIATED WITH THE HIGH IMPEDANCE. IT IS UNKNOWN IF THERE WAS PATIENT MANIPULATION OR TRAUMA THAT MAY HAVE CONTRIBUTED TO THE EVENT. INDICATIONS LISTED IN THE OPERATIVE NOTE STATE THAT THE PATIENT WAS EXPERIENCING INCREASING SEIZURE FREQUENCY WITH GRAND MAL SEIZURES 3 TO 4 PER NIGHT, AND SHE WAS REFERRED FOR SURGERY FOR GENERATOR REPLACEMENT. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE NEUROLOGIST REPORTED THAT THE PATIENT HAS BEEN STABILIZED. NO FURTHER INFORMATION WILL BE SHARED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104643 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 200518

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR