BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    MDR report key: 3153149 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05837
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE VENOGRAM BALLOON PASSIVELY DEFLATED WITH THE STOPCOCK IN CLOSED POSITION. A DIFFERENT BALLOON CATHETER WAS USED. IT WAS ALSO NOTED THAT TWO DIFFERENT GUIDEWIRES BECAME STUCK IN THE LEFT VENTRICULAR (LV) LEAD. EACH WAS EVENTUALLY ABLE TO BE MANIPULATED OUT OF THE LEAD. TRACTION ON THE LAST GUIDEWIRE CAUSED THE LEAD INSULATION TO VISIBLY "PUCKER" ALONG THE BODY OF THE LEAD. THE LEAD DID REMAIN IN POSITION AND TESTED WITHIN NORMAL RANGE. THE LEAD 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
    256035 DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 439688

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR