BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3051184 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04834
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD LOSS OF CAPTURE (LOC.) IT WAS ALSO REPORTED THAT THE LOC WAS DUE TO SLOW LVTO RIGHT VENTRICULAR (RV) CONDUCTION POST-OPERATIVE. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS ARESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152599 ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1