BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 5743655 · Received June 22, 2016

    Report

    Report Number
    2938836-2016-05288
    Event Type
    Injury
    Date Received
    June 22, 2016
    Date of Event
    May 13, 2016
    Report Date
    October 30, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA NUMBER P030054 SHOULD HAVE BEEN REPORTED IN INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT CROSS-TALK WAS OBSERVED DURING DEVICE IMPLANT. PATIENT HAS COMPLETE HEART BLOCK LEADING TO PACING INHIBITION. PROGRAMMING CHANGES WERE MADE AND THE ISSUE WAS RESOLVED. PATIENT WILL CONTINUE TO BE MONITORED WITH ROUTINE FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396369 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40QC P000016043

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention