BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    MDR report key: 2952583 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00620
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD IN THE PROXIMAL AND DISTAL CONDUCTORS (NOT OBSTRUCTED). BY DESIGN, LEFT HEART LEADS ARE MANUFACTURED WITH A SEPTUM IN THE TIP THAT WILL SOMETIMES ALLOW BLOOD INGRESS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD IN A DIFFERENT VESSEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57500 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419678

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR