BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 4832302 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-01528
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    November 26, 2014
    Report Date
    March 16, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT FATIGUE. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH IMPEDANCE AND LOSS OF CAPTURE AT MAXIMUM OUTPUTS. IT WAS NOTED THAT TWO LV LEADS WERE INITIALLY IMPLANTED AND ONE WAS CAPPED TO BE USED ALTERNATIVELY IN CASE THE ACTIVE ONE EXPERIENCED ANY SIGNS OF MALFUNCTION. THE SECOND LV LEAD WAS UNCAPPED AND PLACED INTO THE LV PORT, BUT IT ALSO MEASURED HIGH IMPEDANCE. THE PHYSICIAN SUSPECTED THAT BOTH LEADS MAY HAVE FRACTURED WHERE THEY INTERSECTED. ADDITIONAL INFORMATION FROM THE CLINIC DISCLOSED THE THEY WERE UNABLE TO CONFIRM THE LEAD FRACTURES. THEY DID CONFIRMED THAT THE LEADS WERE EVENTUALLY CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376226 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965-50

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R CD3211-36 ST JUDE ICD, 4965-50 LEAD