BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2040854 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01361
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A CHANGE OUT PROCEDURE FOR NORMAL BATTERY DEPLETION, PACING INHIBITION OCCURRED WHEN THE TERMINAL PIN ON THE CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS INSERTED INTO THE HEADER OF THE NEW PACEMAKER. BOSTON SCIENTIFIC TECHNICAL SERVICES ADVISED THE SALES REPRESENTATIVE (SR) THAT UPON INSERTION THE SET SCREW NEEDS TO BE TIGHTEN BEFORE PACING WILL OCCUR. THE SR STATED THAT ONCE THEY TIGHTEN THE SET SCREW THE DEVICE DID PACE. THE PACEMAKER AND RV LEAD REMAIN IMPLANTED IN THE PACEMAKER DEPENDENT PATIENT. 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 S601

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 4262| 1230| 1286| 4271| S601