BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2151189 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06304
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S RIGHT VENTRICULAR LEAD WAS EXHIBITING IMPEDANCE MEASUREMENTS GREATER THAN 2500 OHMS WITH NO CAPTURE OR SENSING. THE LEAD WAS FOUND TO BE FRACTURED DUE TO A STENT IN THE SUBCLAVIAN VEIN WHICH CRIMPED THE LEAD. A REVISION PROCEDURE WAS PERFORMED TO REPLACE THIS LEAD. HOWEVER, THE LEFT SIDE WAS OCCLUDED AND THERE WAS NO VENOUS ACCESS. THEREFORE, THIS LEAD AND THE ASSOCIATED ATRIAL LEAD WERE BOTH SURGICALLY ABANDONED AND THIS PACEMAKER WAS EXPLANTED. EFFORTS TO IMPLANT THE SYSTEM ON THE RIGHT SIDE WERE UNSUCCESSFUL DUE TO PLACEMENT DIFFICULTY. ADDITIONALLY, THE PATIENT BEGAN COUGHING UP BLOOD AND THE PACEMAKER WAS EXPLANTED AND THE PROCEDURE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1296

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR (B)(4)| (B)(4)| (B)(4)