BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3992346 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09946
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    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 IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEADS IS HIGH AND OUT OF RANGE AND IN UNIPOLAR THEY ARE VERY NOISY. THE LEADS REMAIN 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
    467512 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 6917A

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR 8158 IPG