BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INSYNC

    MDR report key: 1845002 · Received September 22, 2010

    Report

    Report Number
    MW5017562
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    April 15, 2010
    Report Date
    September 22, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FRACTURED ATRIAL AND LEFT VENTRICULAR PACING LEADS. ANALYSIS OF THE PACEMAKER SHOWED FRACTURED LEFT VENTRICLE AND ATRIAL INTERCONNECT RIBBONS. DATES OF USE: (B)(6)2009 - (B)(6)2010. DIAGNOSIS OR REASON FOR USE: COMPLETE HEART BLOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INSYNC PACEMAKER NIK MEDTRONIC, INC. 8042
    2 ATRIAL LEAD LEAD NVN MEDTRONIC 4965-35
    3 LEFT VENTRICULAR LEAD LEADS OJX MEDTRONIC 4965-35

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization