BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2170273 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09586
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 1, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THIS DEVICE SHOULD BE RETURNED TO OUR COMPANY, IT WILL BE ANALYZED AND THIS INVESTIGATION WILL BE REOPENED AND UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES WAS CONSULTED AND SUGGESTED DECREASING THE SENSITIVITY OR GOING TO AN ASYNCHRONOUS MODE WITH RATE HIGHER THAT INTRINSIC TO AVOID ANY ADDITIONAL PAUSES. THE SR WILL SPEAK WITH THE PATIENT'S PHYSICIAN REGARDING PROGRAMMING CHANGES.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS IN THE HOSPITAL FOR NON DEVICE RELATED ISSUES, WHEN A BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) WAS CALLED TO INTERROGATE AS PACING INHIBITION WAS NOTED ON TELEMETRY FOR GREATER THAN 3 SECONDS OF ASYSTOLE. THE PATIENT ALSO EXHIBITED RISING IMPEDANCES ON THE NON BOSTON SCIENTIFIC LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S601

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Life Threatening| O| R S601| MISMATCH| 1170