BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRITY DR

    MDR report key: 4152337 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-06335
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 1, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED FOR ROUTINE CHANGEOUT DUE TO ERI. DURING PROCESSING, THE PULSE GENERATOR EXHIBITED LOSS OF PACING DUE TO CAUTERY. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26482 INTEGRITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CRMD 5366

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR