BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2171143 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10012
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 25, 2011
    Report Date
    June 6, 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

    THE DEVICE REMAINS IN SERVICE. 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 THIS PACEMAKER IMPLANT PROCEDURE, IT WAS OBSERVED THAT BOTH THE POSITIVE SETSCREWS WOULD NOT TIGHTEN DOWN UNTIL THE HEX WRENCH WAS REMOVED AND REINSERTED WHICH ALLOWED FOR THE SETSCREWS TO BE SUCCESSFULLY TIGHTENED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR 1290| 4017| S606| 1283| 4016