BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREEPI

    MDR report key: 3971583 · Received July 31, 2014

    Report

    Report Number
    2182208-2014-01879
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 29, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT ATRIAL (RA) LEAD WARNING WAS RECEIVED INDICATING IMPEDANCE WAS 184 OHMS. IMPEDANCE WAS 205 OHMS AT IMPLANT. THE CALLER WANTED TO PROGRAM THE LEAD MONITOR VALUES AS IMPEDANCE RUNS LOW FOR THIS PATIENT. THERE WERE NO ISSUES NOTED WITH THE LEAD. THE LEAD REMAINS 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
    448300 CAPSUREEPI DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MEDTRONIC, INC. 4965-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00009 YR ADSR01 IPG