BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 2242962 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06590
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    April 19, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.CONTINUED - 1258T/86, (B)(4). (B)(4) REVIEW OF QUALITY RECORDS.

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 1590/60, (B)(4), 1888TC/52, (B)(4),