BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1031611 · Received April 17, 2008

    Report

    Report Number
    MW5006299
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 17, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING CARDIAC CATHERIZATION WITH STENTING, BALLOON ANGIOPLASTY WAS SUCCESSFUL BUT STENT DID NOT DEPLOY, MIGRATED, AND WAS LOST. DIAGNOSIS OR REASON FOR USE: CARDIAC CATHERIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DRIVER BARE METAL STENT MAF MEDTRONIC DRV27518MX 555500

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other