BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2171459 · Received June 30, 2011

    Report

    Report Number
    9612164-2011-00660
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (ROOT CAUSE UNDETERMINED), (DEVICE NOT REC'D FOR EVAL).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING AN INTEGRITY RAPID EXCHANGE (RX) CORONARY STENT FOR TREATMENT OF A LESION. THE DEVICE WAS INSERTED INTO THE PT AND THE BALLOON WAS INFLATED. THE PHYSICIAN NOTED SUB-OPTIMAL RESULTS. THE SHEATH WAS INSPECTED AND THE STENT WAS NOTED TO BE POSITIONED WITHIN THE SHEATH ON THE TABLE. INFO REC'D CONFIRMED THAT THERE WERE NO ISSUES WITH THE DEVICE PACKAGING. THE DEVICE WAS REMOVED FROM THE HOOP AND THE PROTECTIVE SHEATH WAS REMOVED W/O ISSUE. THE PROTECTIVE SHEATH WAS HANDLED CORRECTLY DURING REMOVAL. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRITY RX CORONARY STENT SYSTEM MAF MEDTRONIC IRELAND NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK