BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT SR

    MDR report key: 4191755 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04581
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    August 22, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DXY
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    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. EVALUATION: ANALYSIS NORMAL. DEVICE INTERROGATED FOR FOUR CONSECUTIVE DAYS AND NO NOISE WAS REPRODUCED. NO SET SCREW ANOMALY WAS NOTED AND SET SCREW TIGHTENED PIN WITHIN REQUIRED TORQUE SPECIFICATION. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED MULTIPLE VENTRICULAR NOISE REVERSIONS. THE PULSE GENERATOR WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28346 ACCENT SR IMPLANTABLE PACEMKER PULSE GENERATOR DXY ST. JUDE MEDICAL, CRMD PM1110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention