BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 4131672 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14546
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 14, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, EVIDENCE SUGGESTED THAT THE SILICONE SEAL RINGS WITHIN THE LEAD BARREL HAD BONDED WITH THE SILICONE SEAL RINGS OF THE LEAD. ALL SETSCREWS MOVED FREELY AND OPERATED NORMALLY. THE PACEMAKER PASSED TESTING THAT VERIFIES THE PERFORMANCE OF PACING AND SENSING. THE CLINICAL OBSERVATIONS WERE ABLE TO BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE A ROUTINE CHANGE OUT PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING THE RIGHT ATRIAL (RA) LEAD FROM THE HEADER OF THIS PACEMAKER. THE PHYSICIAN CUT THE BACK OF THE HEADER OFF. THE LEAD WAS THEN ABLE TO BE REMOVED FROM THE DEVICE HEADER. THE DEVICE WAS EXPLANTED. THE RA LEAD WAS SURGICALLY ABANDONED AS THE PATIENT WAS IN CHRONIC ATRIAL FIBRILLATION. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612606 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR K062| 4054| 1297| 4473