BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3993700 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09164
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED THRESHOLD LEVELS. THE LEAD WAS CAPPED AND REPLACED DURING A DEVICE UPGRADE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468534 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR SESR01, IPG