BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX

    MDR report key: 1944052 · Received December 17, 2010

    Report

    Report Number
    1944052
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 15, 2010
    Report Date
    December 17, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    STENT DEPLOYMENT DEVICE, SDS, (UNDEPLOYED STENT) WHEN REMOVED FROM PATIENT NO STENT ON SDS SYSTEM. PATIENT REMAINED STABLE - PROCEDURE CONTINUED - ANOTHER STENT WAS PUT IN. THE FIRST STENT DID NOT DEPLOY AND WAS LEFT IN THE PATIENT.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SEE ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC * 0004606263

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR