BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIDELITY ADX

    MDR report key: 3915852 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08470
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    August 21, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    LWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS REC'D. 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. EVALUATIONS DESCRIPTION: ANALYSIS WAS NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED LOSS OF CAPTURE AND THE PATIENT EXPERIENCED MUSCLE STIMULATION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39570 FIDELITY ADX IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 5384

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention