BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT PLUS DR, DF-4 CONNECTOR

    MDR report key: 1955228 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00470
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 17, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED IMPEDANCE MEASUREMENT ANOMALY WAS NOT REPRODUCED. THE DEVICE WAS TESTED, AND NO ANOMALIES WERE DETECTED. IT IS SUSPECTED THAT THE ANOMALY COULD HAVE BEEN CAUSED BY A LEAD OR LEAD CONNECTION ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIA LEAD IMPEDANCE WAS STABLE UNTIL (B)(6) 2010 AND INCREASED TO OVER 2500 OHMS. THE PATIENT WAS BROUGHT IN TO HAVE THE ATRIAL LEAD REPLACED; HOWEVER, MEASUREMENTS ON THE PSA AND RECONNECTING LEAD INTO THE DEVICE'S HEADER MEASURED APPROXIMATELY 400 OHMS. A LOOSE SETSCREW IN THE FOLLOWING MONTHS OF IMPLANT WAS SUSPECTED. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURRENT PLUS DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention