BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY RX CORONARY STENT SYSTEM

    MDR report key: 2061496 · Received March 16, 2011

    Report

    Report Number
    9612164-2011-00054
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: ROOT CAUSE OF EVENT CANNOT BE IDENTIFIED BASED ON INFORMATION AVAILABLE. STENT DISLODGEMENT. EVALUATION, CONCLUSION: ROOT CAUSE OF EVENT CANNOT BE IDENTIFIED BASED ON INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    AN ATTEMPT WAS MADE TO DEPLOY AN INTEGRITY RAPID EXCHANGE (RX) CORONARY STENT (DETAILS UNK) IN TO A PT; HOWEVER, IT WAS REPORTED THAT THE INTEGRITY STENT DISLODGED UPON REMOVAL FROM THE BODY. NO OTHER 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK