BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3232014 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11402
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    April 7, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRODUCT WAS DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENT INFORMATION WAS RECEIVED THAT APPROXIMATELY ONE MONTH LATER, AN INVASIVE PROCEDURE WAS PERFORMED. THE PACEMAKER SYSTEM WAS EXPLANTED AND REPLACED WITH A NEW SYSTEM. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER IN ASSOCIATION WITH ANOTHER MANUFACTURER'S RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS, EXPERIENCED A SYNCOPAL EPISODE. THE PATIENT EXPERIENCED ASYSTOLE FOR A PERIOD OF EIGHT MINUTES AND WAS HOSPITALIZED. THE PATIENT CONTACTED A BOSTON SCIENTIFIC COMPANY REPRESENTATIVE AND REPORTED THAT PROGRAMMING CHANGES WERE MADE TO THE DEVICE IN THE HOSPITAL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331414 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S205

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R MISMATCH| 4003| 4503| S205