BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC LEAD

    MDR report key: 6923499 · Received October 6, 2017

    Report

    Report Number
    2182208-2017-01627
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    November 13, 2012
    Report Date
    July 21, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXTRACTED DUE T O AN INFECTION. THE PATIENT IS ENROLLED IN THE INCIDENCE OF ARRHYTHMIAS IN SPANISH POPULATION WITH A MEDTRONIC IMPLANTABLE CARDIAC DEFIBRILLATOR IMPLANT (UMBRELLA) REGISTRY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700079 MEDTRONIC LEAD PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R