BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 102

    MDR report key: 2221360 · Received August 24, 2011

    Report

    Report Number
    1644487-2011-01969
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 1, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED WHEN THE SURGEON REPORTED THAT NO X-RAYS WERE TAKEN AND THAT NO PATIENT MANIPULATION OR TRAUMA OCCURRED THAT IS BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. THE SURGEON STATED THAT HE WOULD NOT PROVIDE THE PATIENT'S PROGRAMMING/DIAGNOSTICS HISTORY, BUT THAT ON (B)(6) 2011, THERE WAS NO MENTION OR HIGH IMPEDANCE. THE SURGEON REPORTED THAT THE PATIENT DOES NOT WANT A LEAD REVISION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED WHEN IT WAS DISCOVERED THAT THE HOSPITAL HAD DISCARDED THE EXPLANTED GENERATOR AND THEREFORE IT COULD NOT BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A VNS IMPLANTING SURGEON DISCOVERED THAT THE VNS PATIENT HAD HIGH LEAD IMPEDANCE DURING A PRE-OPERATIVE DIAGNOSTICS TEST THAT DAY. THE PATIENT WAS HAVING A PROPHYLACTIC BATTERY REPLACEMENT SURGERY AND THE PATIENT'S FAMILY DID NOT WANT TO CONSENT TO A FULL REVISION SURGERY WITHOUT THE PATIENT'S INPUT. THE PATIENT WAS ALREADY ASLEEP ON THE TABLE SO HER CONSENT COULD NOT BE OBTAINED AT THAT POINT. THEREFORE, THE PHYSICIAN TRIED TO REINSERT THE LEAD PIN INTO THE GENERATOR TO SEE IF IT WAS JUST A MATTER OF THE PIN COMING OUT OF THE HEADER, BUT LEAD IMPEDANCE WAS STILL HIGH. THE PATIENT'S GENERATOR WAS REMOVED AND THE PATIENT WAS CLOSED UP. NO NEW GENERATOR WAS PUT IN AT THAT TIME. THE PATIENT'S NURSE PRACTITIONER'S NURSE REPORTED THAT THEY HAVE NOT SEEN THE PATIENT SINCE (B)(6) 2011 AND WAS NOT AWARE OF THE HIGH IMPEDANCE. THE PATIENT'S LAST SYSTEM DIAGNOSTICS ON (B)(6) 2011 SHOWED OUTPUT=OK/LEAD IMPEDANCE=OK/IMPEDANCE VALUE=2082OHMS/LESS THAN 20% BATTERY REMAINING. THE SURGEON'S SCHEDULER REPORTED THAT THE PATIENT HAS NOT BEEN SCHEDULED FOR A FULL REVISION SURGERY AT THIS TIME. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE SURGEON ARE UNDERWAY BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 102 LEAD LYJ CYBERONICS, INC. 302-20 1061

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR