BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGEION ANGEPASS

    MDR report key: 1923941 · Received December 14, 2010

    Report

    Report Number
    2184056-2010-00001
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    December 4, 2009
    Report Date
    November 18, 2010
    Manufacturer
    ANGEION CORPORATION
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2010.THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. PLEASE REFER TO THE ATTACHED REPORT NO. ELE 10/180 FOR COMPLETE DETAILS. (B)(4): DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    DELIVERY OF INADEQUATE THERAPY WAS REPORTED TO THE (B)(4) IN ASSOCIATION TO A MEDTRONIC MAXIMO VR, SERIAL NUMBER (B)(4), WHICH WAS REPLACED AFTER 43 MONTHS. THE ANALYSIS OF THE MEDTRONIC DEVICE DID NOT IDENTIFY ANY ANOMALIES, BUT REVIEW OF THE MEMORY SHOWED A LOW HV LEAD IMPEDANCE ASSOCIATED TO THE SUBJECT LEAD. THE IMPLANT STATUS OF THE SUBJECT LEAD IS NOT KNOWN, AND IT IS NOT AVAILABLE FOR ANALYSIS. NOTE: THIS LEAD WAS IMPLANTED AND EXPLANTED OUTSIDE OF THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGEION ANGEPASS LEAD DTB ANGEION CORPORATION ANGEION 4042 176708

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention