BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 304

    MDR report key: 3173892 · Received June 17, 2013

    Report

    Report Number
    1644487-2013-01810
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    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
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED STERILIZATION AND CONFIRMED ALL QUALITY TESTS WERE PASSED FOR BOTH THE GENERATOR AND LEAD PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED MDR INADVERTENTLY OMITTED THE OUTCOME OF CULTURE RESULTS. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS VNS PATIENT UNDERWENT SURGICAL DEBRIDEMENT (WITHOUT DISCONNECTING THE GENERATOR) DUE TO CHRONIC INFLAMMATION IN THE SURGICAL WOUNDS IN THE NECK AND CHEST. THE PATIENT WAS SEEN FOR A VNS CHECK, AND SYSTEM DIAGNOSTICS INDICATED HIGH IMPEDANCE (10000 OHMS). THE DEVICE WAS DISABLED. DURING THE OPERATION, UNIPOLAR ELECTRIC FIELDS WERE USED. IT WAS BELIEVED THAT THE PATIENT HAD A DAMAGED GENERATOR, LEAD, OR BOTH. THE PATIENT WAS REFERRED FOR SURGERY. FOLLOW-UP SHOWED THAT THE CHRONIC INFLAMMATION WAS BELIEVED TO NECK GRANULATION THAT WAS FIRST SEEN A FEW WEEKS PRIOR TO SURGICAL INTERVENTION. THE PHYSICIAN STATED THAT DIAGNOSTICS PRIOR TO THE SURGERY WERE WITHIN NORMAL LIMITS; HOWEVER, AFTERWARDS, THEY INDICATED HIGH IMPEDANCE. NO X-RAYS WERE TAKEN. CULTURES WERE TAKEN AT THE WOUND SITES; HOWEVER, THE RESULTS HAVE NOT BEEN PROVIDED. SURGERY IS LIKELY BUT HAS NOT TAKEN PLACE. NO ADDITIONAL INFORMATION HAS BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013. IT WAS REPORTED THAT THE DEVICE "WORKED 100%". IT WAS LATER REPORTED THAT THE PATIENT WAS SEEN FOR CHECKUP AND THAT IT WAS FOUND THAT THE PATIENT HAS A "BROKEN LEAD". IT WAS REPORTED THAT DURING THE OFFICE VISIT DIAGNOSTICS WERE PERFORMED WITH THE PATIENT'S HEAD A DIFFERENT ORIENTATIONS. IT WAS REPORTED THAT WHEN THE PATIENT TURNED HIS HEAD TO ONE DIRECTION HIGH IMPEDANCE WAS ALWAYS OBSERVED. THEN THE PATIENT TURNED HIS HEAD THE OPPOSITE DIRECTION THE IMPEDANCE WAS "OK". THE PATIENT WAS REFERRED FOR SURGERY AND THE DEVICE WAS PROGRAMMED OFF. SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT CULTURES RETURNED POSITIVE FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272952 LEAD MODEL 304 LEAD LYJ CYBERONICS, INC. 304-20 3182

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention