BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2952163 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00444
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 14, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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) IMPLANTABLE PULSE GENERATOR 2003 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE ON THE RIGHT VENTRICULAR LEAD WAS HIGH. 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
    55817 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR 5554 IMPLANTABLE PACING LEAD