BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOCARDIAL LEAD

    MDR report key: 4158054 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-10706
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 31, 2010
    Report Date
    July 9, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K031274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MYOCARDIAL LEFT VENTRICULAR (MLV) LEAD WAS ATTEMPTED BUT NOT USED DUE TO PLACEMENT DIFFICULTY. AFTER THE PATIENT WAS REMOVED FROM COUMADIN AND THE LUNGS WERE COLLAPSED, A NEW MLV LEAD WAS PLACED. AFTER THE NEW MLV LEAD PLACEMENT, THE PATIENT SUFFERED A STROKE. THE MLV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638628 MYOCARDIAL LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R D274TRK ICD, 6947-65, 5076-52 LEAD