BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSVENOUS LEAD

    MDR report key: 3993064 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09518
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    March 15, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K883743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY : THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED THE LEAD DIAGNOSTICS SHOWED THE ATRIAL LEAD IMPEDANCE HAD GRADUALLY DECREASED WITH A LIFETIME MINIMUM OF 256 OHMS. A POLARITY SWITCH HAD OCCURRED AND THERE WAS AN ATRIAL LEAD WARNING ON (B)(4) 2014.

    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 PRODUCT: ADDR1 IPG IMPLANTED 2009-(B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD HAD LOW IMPEDANCE IN THE BIPOLAR CONFIGURATION AND THE THRESHOLD HAD INCREASED, CONSEQUENTLY A POLARITY SWITCH TO UNIPOLAR OCCURRED. BECAUSE OF THE HIGHER PACING OUTPUT IN THE UNIPOLAR CONFIGURATION, THE DEVICE BATTERY LONGEVITY ESTIMATION DECREASED SO A LEAD REVISION IS BEING CONSIDERED BY THE PHYSICIAN. THE LEAD WILL BE MONITORED AND 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
    468299 TRANSVENOUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4058M52

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR 5024M-58 LEAD