BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVER CORONARY STENT

    MDR report key: 1210404 · Received October 14, 2008

    Report

    Report Number
    1210404
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    September 4, 2008
    Report Date
    October 14, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD STENT PLACED. HAD UNREMARKABLE HOSP COURSE. EIGHT DAYS LATER, PT IN VF ARREST. PT TO CATH LAB WHERE IT WAS DISCOVERED THAT STENT ORIGINALLY PLACED HAD THROMBOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVER CORONARY STENT STENT, CORONARY MAF MEDTRONIC, INC. * 0000723329

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR OTHER| OTHER