BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1843470 · Received September 22, 2010

    Report

    Report Number
    2024168-2010-01980
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    June 3, 2010
    Report Date
    September 13, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE LOT HISTORY RECORD IS FORTHCOMING. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED WEAKNESS IN HER LEGS AND PROBLEMS WITH THE MUSCLES IN THE HIP AND BUTTOCKS SINCE STENT IMPLANTATION. SHE HAS ALSO RECENTLY EXPERIENCED PNEUMONIA SINCE STENT IMPLANTATION. NO ADD'L INFO WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9112561

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention