BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 3739592 · Received April 10, 2014

    Report

    Report Number
    2649622-2014-02424
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    January 6, 2014
    Report Date
    January 6, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, IMPLANTABLE PACING LEAD, 2013-(B)(6); SESR01, IMPLANTABLE PULSE GENERATOR (IPG); 2013-09-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO IMPLANTABLE PACING LEADS ENCOUNTERED NO CAPTURE DUE TO PATIENT EXIT BLOCK. BOTH LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217939 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R 2872 IMPLANTABLE ADAPTOR