BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE ACCEL CRT-D

    MDR report key: 1895797 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04717
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 6, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO INFECTION AND EROSION. THE PHYSICIAN STATED THAT THE LEADS WERE NOT INFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE ACCEL CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3215-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention