BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D, DF-4 CONNECTOR

    MDR report key: 2083882 · Received May 11, 2011

    Report

    Report Number
    2017865-2011-03787
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 31, 2011
    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 Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER AND MEDWATCH FORM WAS RECEIVED. CONTINUED: 2088TC/52, (B)(4). REVIEW OF QUALITY RECORDS.

    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, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention 7122Q/65, (B)(4), 1258T/86, (B)(4),