BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2170271 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09771
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 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

    ALL AVAILABLE INFORMATION INDICATES THAT THESE PRODUCTS REMAIN 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 THIS PACEMAKER DETECTED GREATER THAN 2500 OHMS, NO SENSING AND NO CAPTURE ON THE ATRIAL LEAD. THIS OCCURRED ONE DAY AFTER IMPLANT. THE PATIENT HAD NO SYMPTOMS. THE PHYSICIAN ELECTED TO REOPEN THE POCKET TO REVISE. IT WAS NOTED AT THAT TIME THAT THE SETSCREWS WERE NOT ENTIRELY SECURED. THE SETSCREWS WERE ADJUSTED AND THE LEAD PERFORMED NORMALLY.

    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 Required Intervention