BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2232395 · Received September 2, 2011

    Report

    Report Number
    1644487-2011-02058
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    June 2, 2009
    Report Date
    August 8, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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, THE PATIENT'S PROGRAMMING HISTORY WAS REVIEWED AND IT WAS DISCOVERED THAT THE PATIENT HAS AN IMPEDANCE VALUE OF 558OHMS ON (B)(6) 2009. AN IMPEDANCE VALUE LESS THAN 600 OHMS INDICATES THE POTENTIAL PRESENCE OF A SHORT-CIRCUIT CONDITION. (B)(4) ATTEMPTS ARE UNDERWAY BY THE MANUFACTURER'S CONSULTANT, BUT NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE PHYSICIAN TO DATE. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6), 2011 WHEN THE MANUFACTURER'S CONSULTANT REPORTED THAT THE PHYSICIAN IS GOING TO HAVE THE PATIENT COME BACK IN FOR A CLINICAL VISIT TO RUN DIAGNOSTICS SINCE THE LAST TIME THE PATIENT WAS SEEN WAS SOMETIME IN 2009. THE PATIENT WAS SEEN ON (B)(6), 2011 AND THE PHYSICIAN SAW A LOW IMPEDANCE WARNING MESSAGE UPON INTERROGATION. THE MANUFACTURER'S CONSULTANT REPORTED THAT THE NORMAL MODE DIAGNOSTICS TEST SHOWED AN IMPEDANCE VALUE OF 602OHMS AND A SYSTEMS DIAGNOSTIC TEST SHOWED LOW IMPEDANCE. THE PROGRAMMING HISTORY WAS SENT TO THE MANUFACTURER FOR REVIEW. THE MANUFACTURER'S CONSULTANT REPORTED THAT THE PATIENT IS DOING WELL AND NOT HAVING ANY ADVERSE EVENTS; THEREFORE NO SURGERY WILL OCCUR RIGHT NOW.

    Description of Event or Problem · 1

    ON (B)(4) 2012 CLINIC NOTES WERE RECEIVED DATED (B)(6) 2011. REVIEW OF THE NOTES REVEALED THAT THE PATIENT HAD BORDERLINE LOW IMPEDANCE VALUE OF 558OHMS. THE PATIENT'S VNS HAD NOT BEEN CHECKED SINCE 2009. THE PATIENT'S SETTINGS WERE NOTED TO BE OUTPUT=1.5MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=7SEC/OFF TIME=0.2MIN/MAGNET OUTPUT=1.75MA/MAGNET ON TIME=60SEC/MAGNET PULSE WIDTH=250USEC. SYSTEM DIAGNOSTICS SHOWED THE LEAD IMPEDANCE TO BE 602OHMS WHICH WAS WITHIN NORMAL LIMITS ALTHOUGH BORDERLINE LOW AND THE OUTPUT STATUS WAS "OK." THE LEAD IMPEDANCE WAS CHECKED AGAIN AND IT WAS FOUND TO BE 600OHMS. IT WAS DECIDED THAT THIS WOULD BE WATCHED CAREFULLY. THE PHYSICIAN CHECKED THE BATTERY POSITION AND THE LEADS AND DID NOT SEE ANY EVIDENCE OF ANY ABNORMALITIES. THE MAGNET TEST WAS ALSO PERFORMED AND WAS NORMAL WITH AN IMPEDANCE VALUE OF 602OHMS. TYMPANIC MEMBRANES SHOWED SOME SCARRING BUT NO ACUTE ANOMALIES. THE PATIENT'S MOTHER NOTED SOME POSSIBLE DRAINAGE FROM THE RIGHT EAR BUT THE PHYSICIAN DID NOT SEE ANYTHING ACUTE. THE PHYSICIAN LATER REPORTED ON (B)(6) 2012 THAT THE PATIENT WAS SHOWN TO HAVE "LEAD IMPEDANCE AS WELL AS NEARING END OF SERVICE ON HIS GENERATOR." THE PATIENT WAS REFERRED FOR SURGERY. CLINIC NOTES FROM THE (B)(6) 2012 VISIT WERE ALSO RECEIVED WHICH INDICATED THAT THE LEAD IMPEDANCE WAS GAIN BORDERLINE LOW, AROUND 600OHMS. THE PATIENT'S ON TIME WAS DECREASED TO 0.3SEC AND THE PATIENT'S LEAD IMPEDANCE WAS RE-CHECKED WITH IT STILL SHOWING BORDERLINE LOW. THE PATIENT IS HAVING 3+ SEIZURES A DAY ACCORDING THE PATIENT'S MOTHER; THEY HAVE NOT REALLY CHANGED IN CHARACTER OVER THE LAST YEAR. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN IT WAS DISCOVERED THAT THE PATIENT UNDERWENT A FULL REVISION SURGERY ON (B)(6) 2013. THE LEAD IMPEDANCE AFTER SURGERY WAS NOTED TO BE "OK". THE EXPLANTED PRODUCTS COULD NOT BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS AS THE HOSPITAL DOES NOT RETURN THEM.

    Description of Event or Problem · 1

    ON (B)(4) 2011, ADDITIONAL INFORMATION WAS RECEIVED WHEN THE MANUFACTURER'S CONSULTANT REPORTED THAT SHE IS TRYING TO GET THE PATIENT TO SEE THE PHYSICIAN IN ORDER TO HAVE DIAGNOSTICS PERFORMED. THE PHYSICIAN WAS NOT THERE LAST TIME THE PATIENT AND MANUFACTURER'S CONSULTANT VISITED HIM TO HAVE DIAGNOSTICS PERFORMED. THE PHYSICIAN WAS NOT AWARE OF ANY LOW IMPEDANCE OR CLINICAL SYMPTOMS RESULTING FROM THE LOW IMPEDANCE. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 38902C

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR