BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3862141 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07039
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. CONCOMITANT MEDICAL PRODUCTS: 1388TC LEAD, IMPLANTED: (B)(6) 2004; 694758 LEAD, IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A SLOW STEADY INCREASE IN IMPEDANCE WITH NO VARIANCE NOTED. THE LV LEAD CURRENTLY 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
    341524 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR 7304 CRT-D