BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IROX LEAD W/PEG

    MDR report key: 897037 · Received August 10, 2007

    Report

    Report Number
    2124215-2006-12931
    Event Type
    Injury
    Date Received
    August 10, 2007
    Date of Event
    October 21, 2005
    Report Date
    August 10, 2007
    Manufacturer
    ITM
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. EVENT CONCLUSION INITIALLY, GUIDANT TECHNICAL SERVICES (TS) SPECULATED THAT THE NOISE OBSERVED ON BOTH LEADS WAS DUE TO THE TIGHTENING OF THE PROXIMAL SETSCREW TO THE INSULATION OF THE UNIPOLAR LEADS; EFFECTIVELY BREACHING THE INSULATION AND ALLOWING FOR GREATER SUSCEPTIBILITY TO NOISE DETECTION. LATER, TS SPECULATION WAS CONFIRMED BY THE FIELD BASED ON OBSERVATIONS OF INDUCED DAMAGE TO BOTH LEADS. LATER STILL, THE EXPLANTED LEADS AND DEVICE WERE RETURNED. ALTHOUGH ANALYSIS WAS NOT REQUIRED BASED ON THE AVAILABLE INFORMATION, THE DEVICE WAS ANALYZED, PASSED ALL TESTING, AND WAS DETERMINED TO BE FUNCTIONING APPROPRIATELY. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE REOPENED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS PATIENT REPORTED EXPERIENCING SYNCOPAL EPISODES SHORTLY AFTER THIS PACEMAKER WAS IMPLANTED WITH CHRONIC UNIPOLAR LEADS. THE DEVICE WAS INTERROGATED AND NOISE ON BOTH THE ATRIAL AND VENTRICULAR CHANNELS WAS NOTED. THE DEVICE WAS SUSPECTED TO HAVE OVERSENSED THE NOISE ON THE ATRIAL CHANNEL AND THEREFORE MODE SWITCHED TO VVIR. THE LEADS WERE NOTED TO HAVE ADEQUATE PACING AND SENSING THRESHOLDS. LATER, DURING THE PROCEDURE TO REVISE THE SYSTEM, THE PROXIMAL SETSCREWS WERE NOTED TO HAVE BEEN TIGHTENED ON THE DEVICE AND INSULATION DAMAGE WAS NOTED ON BOTH LEADS IN THE AREA OF THE PROXIMAL SETSCREWS. THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IROX LEAD W/PEG IMPLANTABLE LEAD DTB ITM 431-07

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention 1298| 1292| 433-03| 294-09| 4470