BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS

    MDR report key: 1871533 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17365
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD THIS DEVICE BE RETURNED, ANALYSIS WILL BE PERFORMED OR ADDITIONAL INFORMATION BE OBTAINED, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION, WHEN THE DEVICE WAS REMOVED UPON REMOVAL OF THS RIGHT VENTRICULAR LEAD A VISUAL INSPECTION REVEALED THE LEAD WAS DAMAGED. REPORTEDLY, THE LEAD WAS REMOVED FROM THE DEVICE WITHOUT EXCESSIVE FORCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXUS IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1468

    Patients

    Seq Age Sex Outcome Treatment
    1