BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D, SJ4 CONNECTOR

    MDR report key: 1896074 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04705
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED CONTINUED: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE A BALLOON PINHOLE WAS NOTED. THE 90% STENOSED LESION WAS LOCATED IN A SEVERELY TORTUOUS LEFT COMMON ILIAC ARTERY. IT WAS NOTED THAT CONTRAST MEDIA WAS LEAKING FROM THE WANDA 3.0-20, 80 BALLOON AND A PINHOLE WAS FOUND. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION AND EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE PLUS CRT-D, SJ4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3211-36Q

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention (B)(4)