BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3052676 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03536
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    April 13, 2011
    Report Date
    February 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT WITH THIS DEVICE EXPERIENCED CHEST PAIN AND DYSPNEA.UPON FURTHER REVIEW, IT WAS DISCOVERED THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED (THE MODEL AND SERIAL NUMBER OF THIS LEAD ARE UNKNOWN AT THIS TIME). A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED AND REPLACED. THE DEVICE WAS REPROGRAMMED AT THE TIME OF THE REVISION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154738 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S502

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R