BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3992348 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09925
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCOMITANT MEDICAL PRODUCTS: 5071-53 LEAD, IMPLANTED: (B)(6) 2011; D314TRG ICD, IMPLANTED: (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REACHED EARLY ELECTIVE REPLACEMENT INDICATOR (ERI). IT WAS FURTHER REPORTED THAT THE TWO EPICARDIAL LEFT VENTRICULAR (LV) LEADS, WHICH WERE BIFURCATED TO BIPOLAR, HAD HIGH THRESHOLDS. THE LEAD ADAPTER WAS REMOVED AND EACH LEAD WAS TESTED UNIPOLAR, RESULTING IN A LOWER THRESHOLD. ONE EPICARDIAL LEAD WAS CAPPED, AND THE OTHER 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
    468760 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR 694765 LEAD