BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1647157 · Received March 25, 2010

    Report

    Report Number
    MW5015317
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    March 15, 2010
    Report Date
    March 25, 2010
    Manufacturer
    MEDTRONIC PATIENT SERVICES
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDOVASCULAR DEVICE INSERTED INTO PT FOR PLACEMENT OF STENT GRAFT. DEVICE DID NOT DEPLOY. UPON REMOVAL OF DEVICE, VASCULAR STENT GRAFT PORTON IS CRIMPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ABDOMINAL STENT GRAFT MIH MEDTRONIC PATIENT SERVICES AF3218C155XH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Disability