BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MAXIMO VR

    MDR report key: 810848 · Received January 29, 2007

    Report

    Report Number
    MW1041790
    Event Type
    Injury
    Date Received
    January 29, 2007
    Date of Event
    September 25, 2006
    Report Date
    January 29, 2007
    Manufacturer
    METRONIC, INC
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS PT PRESENTED WITH MULTIPLE INAPPROPRIATE SHOCKS FROM HER SINGLE CHAMBER ICD DUE TO NOISE AND SENSING FROM A FRACTURED RIGHT VENTRICULAR DEFIBRILLATOR LEAD WITH FLUCTUATING AND EXTREMELY HIGH LEAD IMPEDANCES. EXTRACTION OF THE RIGHT VD LEAD AND INSERTION OF A NEW VD LEAD AND NEW SINGLE CHAMBER ICD WERE PERFORMED IN 2006. SHE WAS DISCHARGED HOME TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MAXIMO VR ICD LEAD LWS METRONIC, INC 6949 *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R