BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1946159 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20943
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 19, 2010
    Report Date
    February 9, 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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE AND LEADS WERE EXPLANTED FIVE MONTHS LATER DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REPOSITIONED DUE TO POCKET EROSION. THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD'S WERE DISCONNECTED FROM THE PACEMAKER AND RECONNECTED TO THE PACEMAKER ONCE IT WAS PLACED SUB-PECTORAL. THE FIELD REPRESENTATIVE NOTED DIFFICULTY INTERROGATING THE DEVICE POST REPOSITIONING. UPON USING A NEW PROGRAMMER, THE PACEMAKER WAS SUCCESSFULLY INTERROGATED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE PROCEDURE.

    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 80 YR Life Threatening| R S603| 4269| 1232| 1286