BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCENT MRI DR RF PACEMAKER IDE US

    MDR report key: 4071354 · Received January 14, 2014

    Report

    Report Number
    2017865-2014-08253
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    November 1, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. COMPLAINT COULD NOT BE CONFIRMED. ALL ELECTRICAL AND MECHANICAL MEASUREMENTS WERE WITHIN STANDARD DEVICE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012 THAT ATRIAL OUTPUT CEASED FOR 8 SECONDS DURING REDEPLOYMENT OF THE RIGHT VENTRICULAR LEAD. ON (B)(6) 2012 FAILURE OF ATRIAL PACING WAS OBSERVED; THE OUTPUT WAS INCREASED FORM 3.25V AT 1.0MS TO 5.0V AT 1.0MS. ON (B)(6) 2012 ATRIAL THRESHOLD WAS MEASURED AT 0.75V AT 0.5MS PROMPTING THE PACING OUTPUT TO BE CHANGED TO 3.5V AT 0.5MS. THE PT WAS SYMPTOMATIC AND PRESENTED IN HOSPITAL ON (B)(6) 2012. THE PULSE GENERATOR AND LEADS WERE EXPLANTED AND REPLACED ON (B)(6)2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36405 ACCENT MRI DR RF PACEMAKER IDE US DXY ST. JUDE MEDICAL, INC., CRMD PM2214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention