BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR

    MDR report key: 4153550 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16469
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE SYSTEM WAS EXPLANTED. PATIENTS CONDITION WAS FINE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632275 UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3357-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 7122Q/58, BNY023224