BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUARTET

    MDR report key: 4191784 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04686
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    October 12, 2012
    Manufacturer
    ST. JUDE MEDICAL INC. CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO LOSS OF CAPTURE. DURING THE EXPLANT PROCEDURE THE PHYSICIAN FOUND AN INSULATION ANOMALY AND DAMAGE TO THE SUTURE SLEEVE. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28255 QUARTET PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL INC. CRMD 1458Q/86

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention