BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAEMPRISE DR+

    MDR report key: 4191945 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04561
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 25, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    DXY
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO 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. EVAL: ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THERE WAS NO PACING OUTPUT OBTAINED ON THE PACEMAKER. THE PHYSICIAN NOTED THAT THE LEAD TOP APPEARED ABNORMAL. THE DEVICE AND THE LEAD WERE BOTH REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29764 CAEMPRISE DR+ IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST. JUDE MEDICAL, INC., CARDIAC RHYTHM MANAGEMENT DIVISI 5822

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| (B)(4)