BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D, DF-4 CONNECTOR

    MDR report key: 3892653 · Received June 24, 2014

    Report

    Report Number
    2938836-2014-12284
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    April 7, 2013
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS PRESENTED TO THE EMERGENCY ROOM DUE TO A CHEST WALL HEMATOMA. THE HEMATOMA WAS EVACUATED. THE DEVICE REMAINS IMPLANTED. PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368955 UNIFY QUADRA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3249-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention