BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX

    MDR report key: 2973464 · Received February 22, 2013

    Report

    Report Number
    9612164-2013-00200
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. EVALUATION CONCLUSION: INHERENT RISK OF PROCEDURE-FAILURE TO DELIVER THE STENT AND STENT DEFORMATION. UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO IMPLANT AN INTEGRITY BARE METAL STENT, HOWEVER WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTICED THE STENT STRUT WAS LIFTED. NO CLINICAL SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78203 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1