BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1945648 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20151
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    January 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    P970003
    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.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED FROM THAT PATIENT THAT CARDIOPULMONARY RESUSCITATION (CPR) HAD TO BE PERFORMED DUE TO THE LEAD ISSUE. A REPORT WAS ALSO RECEIVED FROM THE CLINIC THAT STATED THAT THE LEAD HAD FRACTURED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE NOISE ON THE VENTRICULAR CHANNEL WAS NOTED THROUGH THE PACING SYSTEM ANALYZER, BUT CLEARED UP WHEN THE LEAD WAS CONNECTED TO THE DEVICE. THE FOLLOWING DAY NOISE WITH PACING INHIBITION WAS NOTED. A CHEST X-RAY WAS TAKEN AND THE TERMINAL PIN ON THE LEAD APPEARED TO BE THROUGH THE CONNECTOR BLOCK ON THE DEVICE HEADER. BOSTON SCIENTIFIC TECHNICAL SERVICES STATED THAT IT UNCLEAR IF THE NOISE IS BEING CAUSED BY SET SCREW CONNECTION OR A LEAD ISSUE. THE RV LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED WITH THE SAME DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 54 YR Hospitalization| L| R 4136| 4469| S603