BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT DR

    MDR report key: 2905120 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00818
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    May 9, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY LABORATORY TECHNICIAN, NOT APPLICABLE. - ST. JUDE MEDICAL (B)(4) RELIABILITY LABORATORY. NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND AN INTEGRATED CIRCUIT ANOMALY WHICH RESULTED IN AN OUTPUT ANOMALY.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION, IT WAS REPORTED THAT (B)(6) 2012 THE PATIENT RECEIVED A NEW PULSE GENERATOR. UPON INTERROGATION THE ATRIAL LEAD EXHIBITED HIGH IMPEDANCE AND INTERMITTENT SENSING. THE DEVICE WAS EXPLANTED AND REPLACED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12004 ACCENT DR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION PM2112 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention