BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2952300 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00512
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THERE WAS A LEAD WARNING ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO LOW IMPEDANCE. THE LEAD IMPEDANCE HAS TRENDED DOWNWARD OVER TIME. IT WAS ALSO NOTED THAT THERE WERE VENTRICULAR HIGH RATE EPISODES WHICH APPEARED TO BE DUE TO NOISE, ALTHOUGH IT WAS NOT ABLE TO BE REPRODUCED IN THE OFFICE WITH PROVOCATIVE TESTING. 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
    55837 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-35

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)