BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3061854 · Received April 16, 2013

    Report

    Report Number
    1644487-2013-01034
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. X-RAYS REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. DEVICE FAILURE OCCURRED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    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

    THE EXPLANTED LEAD AND GENERATOR WERE RETURNED ON (B)(4) 2013 WITH A RETURNED PRODUCT FORM STATING THAT THE DEVICE WAS EXPLANTED DUE TO LEAD DISCONTINUITY. ANALYSIS OF THE GENERATOR SHOWED THAT THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND. ANALYSIS OF THE LEAD SHOWED THAT THE LEAD DISCONTINUITY ALLEGATION WAS CONFIRMED. A SMALL PORTION OF THE LEAD ASSEMBLY (BODY) WAS NOT RETURNED FOR ANALYSIS AND THEREFORE A COMPLETE EVALUATION COULD NOT BE PERFORMED ON THE ENTIRE LEAD PRODUCT. DURING THE VISUAL ANALYSIS OF THE RETURNED PORTION THE POSITIVE WHITE ELECTRODE QUADFILAR COIL APPEARED TO BE BROKEN AT THE PROXIMAL END OF THE ANCHOR TETHER. SCANNING ELECTRON MICROSCOPY (SEM) WAS PERFORMED AND IDENTIFIED THE AREA AS BEING MECHANICALLY DAMAGED WITH PITTING WHICH PREVENTED IDENTIFICATION OF THE COIL FRACTURE TYPE. PITTING WAS OBSERVED ON THE COIL SURFACE. IT IS BELIEVED THAT STIMULATION WAS PRESENT FOR A CERTAIN PERIOD OF TIME AS EVIDENCED BY THE PRESENCE OF METAL PITTING. LOW MAGNIFICATION SEM ANALYSIS OF THE QUADFILAR COIL SHOWS CHARACTERISTICS TYPICAL OF A LEAD DISCONTINUITY. WITH THE EXCEPTION OF THE OBSERVED DISCONTINUITY, THE CONDITION OF THE RETURNED LEAD PORTIONS IS CONSISTENT WITH CONDITIONS THAT TYPICALLY EXIST FOLLOWING AN EXPLANT PROCEDURE. NO OTHER OBVIOUS ANOMALIES WERE NOTED. THE RESISTANCE MEASUREMENTS TAKEN DURING DECONTAMINATION VERIFIED AN ELECTRICAL AND MECHANICAL CONTACT BETWEEN THE GENERATOR AND CONNECTOR PIN AT ONE POINT IN TIME. CONTINUITY CHECKS OF THE RETURNED LEAD PORTIONS WERE PERFORMED, DURING THE VISUAL ANALYSIS, AND NO OTHER DISCONTINUITIES WERE IDENTIFIED. X-RAYS WERE RECEIVED AND REVIEWED: THE GENERATOR IS VISUALIZED IN A NORMAL PLACEMENT IN THE LEFT UPPER CHEST. THE FILTER FEED-THROUGH WIRES APPEAR TO BE INTACT, AND THE LEAD CONNECTOR PINS APPEARS TO BE FULLY INSERTED INTO THE GENERATOR CONNECTOR BLOCK. THE LEAD IS VISIBLE, APART FROM A SECTION OF THE LEAD THAT IS BEHIND THE GENERATOR. THE LEAD WIRES APPEAR INTACT AT THE CONNECTOR PINS. A LEAD BREAK WAS NOT OBSERVED IN THE ASSESSED PORTION. REVIEW OF PROGRAMMING HISTORY SHOWED THAT A SYSTEM DIAGNOSTIC ON (B)(6) 2012 WAS WITHIN NORMAL LIMITS; HOWEVER, DIAGNOSTIC ON (B)(6) 2013 INDICATED HIGH IMPEDANCE. THE DEVICE WAS DISABLED ON (B)(6) 2013.

    Description of Event or Problem · 1

    REPORTER INDICATED A PATIENT HAD HIGH LEAD IMPEDANCE WITH VNS DIAGNOSTICS TESTING ON (B)(6) 2013. THE VNS WAS DISABLED AND THE PATIENT WAS SENT FOR X-RAYS. SURGERY TO REVISE THE VNS APPEARS LIKELY, BUT HAS NOT OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL INFORMATION ARE IN PROGRESS.

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED TO THE MANUFACTURER INDICATING DEVICE DIAGNOSTICS WERE WITHIN NORMAL LIMITS WITH THE NEW VNS GENERATOR AND LEAD THAT WAS IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163929 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 2239

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR