BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 5172842 · Received October 24, 2015

    Report

    Report Number
    2124215-2015-11186
    Event Type
    Injury
    Date Received
    October 24, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 19, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 HIGH OUT OF RANGE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCES. A LEAD FRACTURE WAS SUSPECTED BUT NOT CONFIRMED. SURGICAL INTERVENTION WAS PERFORMED AND THE COMPETITIVE RV LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704730 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R