BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3990503 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08624
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 4558M53, LEAD, (B)(6) 1996. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE CHANGE OUT, THE ATRIAL LEAD SHOWED LOW PACING IMPEDANCE. THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO BE KINKED IN POCKET WITH QUESTIONABLE INTEGRITY. THERE WAS NO DYSFUNCTION NOTED AND ALL MEASUREMENTS WERE STABLE. HOWEVER, DUE TO THE PATIENTS' DEPENDENT STATUS AND THE AGE OF THE RV LEAD, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LEAD. BECAUSE OF THIS, THE PHYSICIAN DECIDED TO LEAVE THE ATRIAL LEAD IN PLACE. THE ATRIAL LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467809 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R SDR203B IPG