BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2052677 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03839
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 25, 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE CHANGE OUT PROCEDURE, THERE WAS NOISE AND NO CAPTURE FOR THE RIGHT VENTRICULAR (RV) LEAD. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE NOTED THAT THE PATIENT IS PACEMAKER DEPENDENT AND THE PHYSICIAN WAS IN A RUSH TO FINISH THE PROCEDURE. UPON FURTHER INVESTIGATION, IT WAS DISCOVERED THAT THE RV LEAD WAS NOT FULLY INSERTED INTO THE DEVICE HEADER. THE ISSUE WAS RESOLVED PRIOR TO POCKET CLOSURE AS THE PHYSICIAN RESECURED THE LEAD AND ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. THE PATIENT DID NOT EXPERIENCE ANY ASYSTOLE AS A TEMPORARY PACING WIRE WAS IN PLACE FOR THE PROCEDURE. THE DEVICE AND LEAD REMAIN IN SERVICE. 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 85 YR S603| 1296| 4161| MISMATCH| 4130| 1230| 0523