BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3289627 · Received August 15, 2013

    Report

    Report Number
    1644487-2013-02418
    Event Type
    Malfunction
    Date Received
    August 15, 2013
    Date of Event
    July 19, 2013
    Report Date
    July 22, 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 WERE REVIEWED BY THE MANUFACTURER, UNABLE TO ASSESS IF LEAD PIN FULLY INSERTED PAST THE CONNECTOR BLOCK OF GENERATOR IN IMAGES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT HIGH LEAD IMPEDANCE, WITH IMPEDANCE VALUE GREATER THAN OR EQUAL TO 10,000 OHMS, WAS DETECTED THROUGH SYSTEM DIAGNOSTICS. SINCE THE EVENT OCCURRED, THE PHYSICIAN HAS TURNED THE DEVICE OFF (TO 0MA) AND PLANS TO PERFORM AN OPERATION TO RESOLVE THE MATTER. THIS SURGERY OCCURRED ON (B)(6) 2013. NO MANIPULATION OR TRAUMA OCCURRED. REVIEW OF THE MANUFACTURER'S DEVICE HISTORY RECORDS FOR THE LEAD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. REVIEW OF THE PROGRAMMING HISTORY REVEALED THAT THE HIGH IMPEDANCE WAS OBSERVED ON (B)(6) 2013. A/P CHEST X-RAYS AND A/P AND LATERAL NECK X-RAYS WERE RECEIVED AND REVIEWED BY THE MANUFACTURER. THE GENERATOR WAS SEEN IN THE LEFT CHEST. DUE TO THE QUALITY AND ANGLE OF THE X-RAY, IT IS UNABLE TO BE ASSESSED IF THE CONNECTOR PIN IS FULLY INSERTED. THE FILTER FEEDTHRU WIRES AND THE LEAD WIRES AT THE LOCATION OF THE CONNECTOR PINS APPEAR TO BE INTACT. IT APPEARS THAT A PORTION OF THE LEAD IS LOCATED BEHIND THE GENERATOR THAT COULD NOT BE ASSESSED. THE ELECTRODE PLACEMENT APPEARED NORMAL. BASED ON THE PROVIDED IMAGES, IT APPEARS THAT THERE IS A STRAIN RELIEF LOOP AND BEND PRESENT. TWO TIE-DOWNS ARE SECURING THE BEND, BUT IT IS UNABLE TO BE ASSESSED IF A TIE-DOWN IS SECURING THE LOOP. HOWEVER, IT IS UNLIKELY THAT THE LOOP WOULD REMAIN WITHOUT A TIE-DOWN. THERE DID NOT APPEAR TO BE ANY LEAD DISCONTINUITIES OR SHARP ANGLES IN THE LEAD PORTION THAT WAS ABLE TO BE VISUALIZED. BASED ON THE X-RAY IMAGES PROVIDED, THE CAUSE OF THE HIGH IMPEDANCE CANNOT BE DETERMINED. A PORTION OF THE LEAD COULD NOT BE VISUALIZED IN THE CHEST, AND THE PRESENCE OF A MICRO-FRACTURE IN THE LEAD CANNOT BE RULED OUT. ADDITIONALLY DUE TO THE QUALITY OF IMAGES, THE LEAD PIN NOT BEING FULLY INSERTED COULD NOT BE RULED AS A POTENTIAL CAUSE OF THE HIGH IMPEDANCE. ADDITIONAL INFORMATION WAS RECEIVED ON THE DAY OF SURGERY THAT SURGERY HAD BEEN PERFORMED AS SCHEDULED. IT WAS PLANNED TO FIRST SEE THE CONNECTION STATE OF THE GENERATOR AND LEAD. DURING SURGERY, IT WAS DISCOVERED THAT THE "LOOSENESS OF THREADED JOINTS FOR CONNECTION WITH THE GENERATOR AND LEAD HAD CAUSED THE HIGH LEAD IMPEDANCE." AFTER THE PHYSICIAN RECONNECTED THESE PARTS BY FOLLOWING THE APPROPRIATE STEPS, ANOTHER SYSTEM DIAGNOSTIC TEST WAS PERFORMED AND HIGH LEAD IMPEDANCE WAS NOT SEEN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394162 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS INC 103 201776

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR