BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2052190 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03908
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, BOTH THE DEVICE AND RV LEAD REMAIN IMPLANTED. 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 THE PATIENT WITH THIS PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD FELL WHILE IN REHABILITATION. IT WAS DISCOVERED THAT THERE WAS A WIRE PROTRUDING FROM THE PATIENT'S SKIN. IT IS UNKNOWN IF THE WIRE IS DUE TO THE IMPLANTED PRODUCTS. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WAS SCHEDULED FOR A FOLLOW UP, BUT DID NOT ATTEND THE APPOINTMENT.

    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 92 YR Life Threatening| O 4456| S601