BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3140204 · Received May 31, 2013

    Report

    Report Number
    1644487-2013-01636
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 8, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 INDICATED THAT THE PATIENT REPORTS THAT APPROXIMATELY ONE MONTH AFTER THE PATIENT'S PREVIOUS VISIT SHE FOUND SHE COULD NO LONGER FEEL VNS STIMULATION. IT WAS NOTED THAT LEAD TEST RESULTED IN A HIGHER THAN EXPECTED IMPEDANCE INDICATING A POSSIBLE LEAD DISCONTINUITY. CLINIC NOTES DATED (B)(6) 2013 INDICATED THAT THE PATIENT WAS NO LONGER HAVING NOTICEABLE HOARSENESS OR COUGHING WITH VNS STIMULATION. FURTHER FOLLOW-UP WITH THE TREATING PHYSICIAN INDICATED THAT THE DEVICE WAS NOT PROGRAMMED OFF AFTER OBSERVING THE HIGH IMPEDANCE. NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE OR THE PATIENT NO LONGER FEELING STIMULATION. NO CAUSAL OR CONTRIBUTORY PROGRAMMING OR MEDICATION CHANGES PRECEDED THE ONSET OF THE PATIENT NO LONGER FEELING STIMULATION. THE PHYSICIAN ALSO INDICATED THAT LEAD REPLACEMENT IS PLANNED; HOWEVER, SURGERY HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 WERE RECEIVED WHICH INDICATE THAT THE PATIENT'S MOTHER CALLED AND REPORTED THAT THE PATIENT IS TAKING LAMICTAL, BUT IT IS NOT WORKING AS GOOD AS THEY THOUGHT IT WOULD. PER THE MOTHER, THE PATIENT WOULD LIKE TO GO AHEAD AND HAVE THE LEAD REVISED. THE PATIENT IS HAVING AN EPISODE BY SIX OR SEVEN IN THE EVENING WHICH LASTS FOR APPROXIMATELY 30 TO 40 MINUTES. DURING THE DAY THE PATIENT IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROLOGIST INCREASED THE PATIENT'S LAMICTAL TO EXTENDED RELEASE TO SEE IF THE PATIENT'S SEIZURES CAN BE CONTROLLED WITH MEDICATIONS ONLY. THE PATIENT WAS INSTRUCTED TO CALL THE NEUROLOGIST IF SHE NOTICES AN INCREASE IN SEIZURES. THE PATIENT PLANS TO TRY THE MEDICATION INCREASE FOR APPROXIMATELY TWO MONTHS BEFORE MAKING A SURGICAL DECISION. THE PATIENT'S MOTHER INDICATED THAT THE PATIENT HAS EXPERIENCED A GOOD RESPONSE TO VNS THERAPY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, AN IMPLANT CARD WAS RECEIVED INDICATING THE VNS GENERATOR AND LEAD WERE REPLACED DUE TO LEAD DISCONTINUITY. THE EXPLANTED DEVICE IS NOT RETRIEVABLE AS IT HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242464 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 010904

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR