BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2852572 · Received November 30, 2012

    Report

    Report Number
    1644487-2012-03157
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR AND LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ON (B)(6) 2012 IT WAS REPORTED THAT THE VNS PATIENT SHOWED HIGH IMPEDANCE THAT MORNING DURING DIAGNOSTIC TESTING. THE PATIENT WAS REFERRED FOR NECK AND CHEST X-RAYS TO LOOK FOR A LEAD FRACTURE. THERE WAS NO OBVIOUS DIRECT INJURY TO THE DEVICE REPORTED, ALTHOUGH THE PATIENT FELL ONTO SOMEONE RECENTLY IN A SEIZURE AND HURT HER CHIN SLIGHTLY. THE PATIENT'S OUTPUT CURRENT WAS DECREASED BY 0.25MA AND WAS THEN DISABLED ON (B)(6) 2012 DUE TO THE HIGH IMPEDANCE. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH SHOWED 2.75 YEARS REMAINING UNTIL ERI=YES. IT WAS LATER REPORTED THAT THE X-RAYS WERE REVIEWED AND THEY DID NOT SHOW AN OBVIOUS LEAD DISCONTINUITY. IT WAS UNKNOWN IF THE LEAD PIN WAS FULLY INSERTED INTO THE HEADER OF THE GENERATOR. IT WAS ALSO REPORTED THAT PRIOR TO THE HIGH IMPEDANCE MESSAGE, THE PREVIOUS NORM MODE DIAGNOSTICS IN (B)(6) 2012 SHOWED A DCDC OF 5 AND THE PATIENT'S SETTINGS AT THAT TIME WERE OUTPUT=2.25MA/FREQUENCY=30HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=5MIN. THE PATIENT WAS REFERRED FOR REVISION SURGERY. ALTHOUGH SURGERY IS LIKELY IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE GENERATOR AND LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. THE PHYSICIAN REPORTED THAT THERE WAS A LOT OF SCARRING AROUND THE ¿ATTACHMENT SITE OF THE VAGUS NERVE AND THE LEAD¿. THE PHYSICIAN STATED THAT THEREFORE THE LEAD WAS REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013 WHEN PRODUCT ANALYSIS WAS COMPLETED ON THE EXPLANTED GENERATOR. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND THERE WAS NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION FOUND.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013 WHEN IT WAS DISCOVERED THAT THE PATIENT HAD UNDERGONE SURGERY ON (B)(6) 2013. THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2013 FOR PRODUCT ANALYSIS. IT WAS UNKNOWN IF THE LEADS WERE REPLACED AS WELL. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    AN IMPLANT CARD RECEIVED ON (B)(6) 2014 INDICATED THAT THIS VNS PATIENT UNDERWENT FULL REVISION ON (B)(6) 2013 DUE TO HIGH IMPEDANCE. POST-OPERATIVE IMPEDANCE WAS WITHIN NORMAL LIMITS AT 1496 OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1556

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR