BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENGUARD PFX

    MDR report key: 3881184 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-02173
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 10, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT DUE TO NORMAL ERI, LOW HV SHOCK IMPEDANCE WAS OBSERVED. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30368 ENGUARD PFX DEFIBRILLATION LEAD DTB ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 040-068-65

    Patients

    Seq Age Sex Outcome Treatment
    1