BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3243177 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02224
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 27, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT LEAD TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCE. SYSTEM DIAGNOSTICS WERE PERFORMED, WHICH REVEALED A DCDC CODE OF 7 AND HIGH IMPEDANCE. THE PATIENT'S LAST SETTINGS WERE 1.75 MA OUTPUT CURRENT, 20 HZ FREQUENCY, 250 MICROSECONDS PULSEWIDTH, 30 SECOND ON TIME, 3 MINUTES OFF TIME, 1.75 MA MAGNET OUTPUT CURRENT, 60 SECONDS MAGNET ON TIME, 250 MICROSECONDS MAGNET PULSEWIDTH. THE PATIENT WAS SUPPOSED TO SEE THE NEUROLOGIST ON (B)(6) 2013 TO HAVE THE DEVICE DISABLED. IT WAS UNKNOWN IF ANY MANIPULATION OR TRAUMA OCCURRED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. CLINIC NOTES DATED (B)(6) 2013 NOTE THAT THE PATIENT'S VNS BATTERY IS LOW AND THERE IS A FAILURE. THE NOTES STATE THAT THE PATIENT WILL BE REFERRED TO THE SURGEON FOR A BATTERY AND LEAD REPLACEMENT VS. REPAIR. NOTES DATED (B)(6) 2013 INDICATE THE RADIOLOGIST CALLED THE PHYSICIAN TO RELAY THE X-RAY RESULTS. CHEST AND NECK X-RAYS SHOW THAT THE "WIRES ARE INTACT" AND THERE IS "NO FRANK DISRUPTION OF THE LEAD". PA AND LATERAL VIEWS OF THE CHEST DEMONSTRATE NORMAL CARDIAC AND MEDIASTINAL CONTOURS. MILD EMPHYSEMA IS NOTED THE LUNGS ARE OTHERWISE CLEAR. NO ACUTE BONE ABNORMALITY IS IDENTIFIED. A NEURAL STIMULATOR IS IN PLACE ON THE LEFT. THE VISUALIZED PORTION OF THE LEAD COURSING UPWARD ALONG THE ANTERIOR LEFT CHEST APPEARS INTACT TO THE BASE OF THE NECK, WHERE THERE IS A COILED, BUT NO FRANK DISRUPTION OF THE LEAD IS IDENTIFIED TO THE SUPERIOR MARGIN OF THE FILM." "NEURAL STIMULATOR LEADS APPEAR INTACT, WITH NO FRANK DISRUPTION OF THE LEADS IDENTIFIED, ALTHOUGH THERE IS A INFERIORLY DIRECTED LOOP IN THE CATHETER AT THE LEVEL OF THE BASE OF THE NECK. THE LEADS TERMINATE IN THE ANTERIOR SOFT TISSUES AT THE LEVEL OF THE C8 VERTEBRAL BODY." THE X-RAYS WERE NOT SENT TO THE MANUFACTURER FOR REVIEW. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE EXPLANTED GENERATOR WAS RETURNED TO THE MANUFACTURER ON (B)(4) 2013. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS OF THE CURRENT AUTOMATED FINAL TEST 102. ANALYSIS IN THE PRODUCT ANALYSIS LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED ON (B)(4) 2013 INDICATING THE DEVICE WAS EXPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342315 LEAD MODEL 302 LEAD LYJ CYBERONICS, INC. 302-20 1528

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR