BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 2232295 · Received August 26, 2011

    Report

    Report Number
    MW5021940
    Event Type
    Injury
    Date Received
    August 26, 2011
    Report Date
    August 26, 2011
    Manufacturer
    MEDTRONIC INC
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ICD RV LEAD IMPEDANCE INCREASE FROM 437-494 OHMS TO 1786 OHMS INDICATING A LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC RIGHT VENTRICULAR LEAD FOR IMPLANTABLE DEFIBRILLATOR DTB MEDTRONIC INC 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S