BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2151673 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06826
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES DISCUSSED A POSSIBLE LEAD DISLODGEMENT OR LOOSE CONNECTION. THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THIS PRODUCT 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD INDICATING AN INVASIVE PROCEDURE WAS PERFORMED TO ASSESS THE LEAD. THERE NO SIGNS OF ANY BREAKS IN LEAD INTEGRITY AND TESTING VIA A PACING SYSTEM ANALYZER (PSA) FOUND ADEQUATE MEASUREMENTS. THE LEAD WAS REPOSITIONED TO A MORE SEPTAL POSITION AND AGAIN ADEQUATE MEASUREMENTS WERE OBSERVED. AT THIS TIME, IT WAS SUSPECTED THAT THE HIGH MEASUREMENTS WERE DUE TO POSSIBLE LEAD LOCATION OR PACING VECTOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT VENTRICULAR (RV) PACING LEAD EXHIBITED LOSS OF CAPTURE. AN RV LEAD SAFETY SWITCH WAS ALSO OBSERVED, HOWEVER IMPEDANCE MEASUREMENTS FOLLOWING THE LEAD SAFETY SWITCH WERE 500 OHMS IN BIPOLAR AND 780 OHMS IN UNIPOLAR. THE RV AMPLITUDE MEASUREMENTS WERE 9MV IN BIPOLAR AND 2MV IN UNIPOLAR. 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 79 YR Required Intervention (B)(4)| (B)(4)| (B)(4)