BEUDAMED
    FDA Adverse Event Summary report: N

    MEDTRONIC VIRTUOSO II

    MDR report key: 3060162 · Received April 10, 2013

    Report

    Report Number
    MW5029746
    Date Received
    April 10, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ABNORMAL READING OF LOW LEAD IMPEDANCE FOUND DURING TESTING OF ICD (RV LEAD). MEDTRONIC GENERATOR DID NOT FULLY CHARGE. PT TRANSPORTED TO OPERATING ROOM FOR SYSTEM EXTRACTION AND IMPLANT OF NEW ICD SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150240 MEDTRONIC VIRTUOSO II GENERATOR LWS MEDTRONIC VIRTUOSO II
    150241 ST. JUDE, DURATA RV LEAD LWS ST. JUDE MEDICAL 7121-65

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention