BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY RX

    MDR report key: 2944909 · Received February 6, 2013

    Report

    Report Number
    9612164-2013-00123
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 31, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MAF
    PMA / PMN Number
    P030009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (RESTENOSIS).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PATIENT HAD AN INTEGRITY RAPID EXCHANGE (RX) CORONARY STENT IMPLANTED IN THE RCA. APPROXIMATELY 28 MONTHS POST PROCEDURE THE PATIENT UNDERWENT A REVASCULARIZATION OF THE RCA. PATIENT HAD A NON-MEDTRONIC STENT IMPLANTED. APPROXIMATELY 5 MONTHSLATER THE PATIENT UNDERWENT ANOTHER REVASCULARIZATION OF THE RCA. PATIENT HAD A NON-MEDTRONIC STENT IMPLANTED.

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED TVR EVENT OCCURRED APPROXIMATELY 3 MONTHS POST INTEGRITY STENT IMPLANT NOT 28 MONTHS AS PREVIOUSLY REPORTED. APPROXIMATELY 13 MONTHS POST INTEGRITY STENT IMPLANT A REVASCULARIZATION OF THE RCA WAS CARRIED OUR WHERE AN INTEGRITY STENT WAS IMPLANTED. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS. PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50451 INTEGRITY RX STENT, CORONARY MAF MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASPIRIN, CLOPIDOGREL