BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2042403 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02130
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPANTED. AS OF TODAY, THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ELECTIVE DEVICE UPGRADE PROCEDURE, THE PATIENT WITH THIS DEVICE DEVELOPED VENTRICULAR FIBRILLATION. THE PATIENT RECEIVED AN EXTERNAL SHOCK AND CONVERTED. IT WAS SUSPECTED THAT THE INTERACTION BETWEEN THE DEVICE AND THE ELECTROSURGICAL CAUTERY TOOL CAUSED THE ARRHYTHMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening| R N119| 4469| 4543| 6947| 4136| S603