BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1853253 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14393
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 16, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC CRM. SHOULD ADDITOINAL INFORMATION BECOME AVAILABLE AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER WAS EXPLANTED DUE TO A POSSIBLE INFECTION AND/OR ALLERGIC REACTION. THE RIGHT VENTRICULAR LEAD MAY NEED TO BE EXPLANTED IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S501

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention