BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3993004 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09541
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. CONCOMITANT MEDICAL PRODUCTS: 5071-35 LEAD, IMPLANTED: (B)(6) 2013; 4968-35 LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TWO RIGHT VENTRICULAR (RV) EPICARDIAL LEADS THAT WERE ADAPTED TOGETHER AND WERE OVERSENSING TWAVES. THE LEADS WERE REPROGRAMMED AND 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
    468117 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention ADDRL1 IPG