BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 4131779 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14433
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 10, 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

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, MICROSCOPIC VISUAL INSPECTION OF THE LEAD BARRELS AND INNER SEAL RINGS IDENTIFIED EVIDENCE THAT THE SILICONE SEAL RINGS WITHIN THE LEAD BARREL HAD BONDED WITH THE SILICONE SEAL RINGS OF THE LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING ROUTINE REPLACEMENT OF THIS PACEMAKER, THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE UNABLE TO BE REMOVED FROM THE DEVICE HEADER. THE PATIENT WAS PACEMAKER DEPENDENT. THE BACK OF THE HEADER WAS CUT AND THE LEADS WERE THEN SUCCESSFULLY REMOVED AND CONNECTED TO THE REPLACEMENT DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612690 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4473| 4472| K174| 1297