BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPOL LEAD MODEL 300

    MDR report key: 2993692 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00627
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    November 28, 2007
    Report Date
    February 6, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    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 IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A PHYSICIAN'S ASSISTANT REPORTED THAT THE PATIENT WAS REFERRED FOR GENERATOR AND LEAD REPLACEMENT DUE TO HIGH IMPEDANCE DETECTED IN 2007 WHEN THE PATIENT WAS TREATED AT ANOTHER FACILITY. THE PATIENT NOW WANTS TO MOVE FORWARD WITH REVISION SURGERY, BUT THE PHYSICIAN'S ASSISTANT HAS NO RECORDS OF THE PATIENT INCLUDING VNS SETTINGS SO COULD NOT PROVIDE DETAILS OF THE CASE. THERE WAS NO HISTORY OF MANIPULATION OR TRAUMA THAT COULD HAVE CONTRIBUTED TO THE HIGH IMPEDANCE. THE DEVICE HAS BEEN TURNED OFF SINCE THE HIGH IMPEDANCE WAS DETECTED ON (B)(6) 2007, PER MANUFACTURER'S REVIEW OF PROGRAMMING HISTORY. THE PHYSICIAN'S ASSISTANT REPORTED THE X-RAYS TAKEN ON (B)(6) 2007 WERE NORMAL. NO PATIENT ADVERSE EVENTS WERE REPORTED. A/P AND LATERAL X-RAYS OF THE CHEST AND NECK WERE PROVIDED TO THE MANUFACTURER FOR REVIEW. THERE DID NOT APPEAR TO BE ANY LEAD DISCONTINUITIES OR SHARP ANGLES IN THE LEAD PORTION THAT WAS ABLE TO BE VISUALIZED THE GENERATOR WAS SEEN IN THE LEFT CHEST. THE FILTER FEED-THRU WIRES WERE INTACT. THE LEAD PINS APPEARED TO BE FULLY INSERTED INTO THE HEADER OF THE GENERATOR. THE LEAD WIRE APPEARED TO BE INTACT AT THE LOCATION OF THE CONNECTOR PINS. THERE WAS A SMALL PORTION OF THE LEAD LOCATED BEHIND THE GENERATOR THAT COULD NOT BE ASSESSED. BASED ON THE X-RAY IMAGES PROVIDED, AN EXACT CAUSE FOR THE REPORT OF HIGH IMPEDANCE COULD BE DETERMINED. HOWEVER, A SMALL PORTION OF THE LEAD COULD NOT BE VISUALIZED IN THE CHEST DUE TO IT BEING BEHIND THE GENERATOR. ALSO, THE PRESENCE OF A MICRO-FRACTURE IN THE LEAD CANNOT BE RULED OUT. ALTHOUGH SURGERY IS LIKELY, IT HAS NOT OCCURRED TO DATE. REVIEW OF THE LEAD DEVICE HISTORY RECORD CONFIRMED THAT ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. NO ANOMALIES OBSERVED.

    Description of Event or Problem · 1

    THE PATIENT HAD GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2013. THE EXPLANTED PRODUCTS ARE NO LONGER AVAILABLE FOR RETURN TO THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    THE IMPLANT CARD WAS RECEIVED BY THE MANUFACTURER AND CONFIRMED THE GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2013. THE REASON FOR SURGERY WAS LISTED AS "ABNORMAL DIAGNOSTICS--? LEAD FRACTURE." LEAD IMPEDANCE FOLLOWING REPLACEMENT SURGERY WAS REPORTED TO BE OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98310 BIPOL LEAD MODEL 300 LEAD LYJ CYBERONICS, INC. 300-20 5316

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR