BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 7084497 · Received December 5, 2017

    Report

    Report Number
    2938836-2017-34629
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    October 23, 2017
    Report Date
    January 25, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED TO RECEIVE A COMPETITOR SUB-Q HV ARRAY, DUE TO A VT/VF EVENT AND BECAUSE THE FIRST SHOCK DID NOT RESCUE THE PATIENT AND THE PATIENT WAS RESCUED BY AN EXTERNAL DEFIBRILLATOR. THE PATIENT WAS TESTED IN CATH LAB AND DFT TEST WAS NOT SUCCESSFUL. ON (B)(6) 2017, THE DEVICE WAS ELECTIVELY REMOVED SINCE THE POCKET IS OPEN FOR THE ARRAY PLACEMENT. NO EVIDENCE OF LITHIUM DEPOSIT PROBLEM. IT IS BELIEVED THAT THE FAILED HV SHOCK WAS DUE TO PATIENT FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864707 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3231-40 3403667

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention