BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET TIP

    MDR report key: 3153436 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06012
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K844974
    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 PRODUCTS: 5026 IMPLANTABLE PACING LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON INTERROGATION IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD IMPEDANCE WAS LOW, WITH UNIPOLAR IMPEDANCE HIGHER THAN BIPOLAR, AND A POLARITY SWITCH HAD OCCURRED. THE LEAD IS STILL 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
    258991 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4512

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR ADDR03 IMPLANTABLE PULSE GENERATOR (IPG)