BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRITY DR

    MDR report key: 4152196 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-06601
    Event Type
    Injury
    Date Received
    January 13, 2014
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. FINAL ANALYSIS FOUND THE DEVICE IN BACKUP VVI DUE TO A NON-MASKED INTERRUPT. AFTER A SOFTWARE DOWNLOAD WAS PERFORMED, THE DEVICE WAS ABLE TO SUCCESSFULLY BE INTERROGATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS UNABLE TO BE INTERROGATED AND EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22585 INTEGRITY DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 5366

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention