BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET TIP

    MDR report key: 3152590 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06740
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K822781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 LEAD MONITOR REPORTED AND ATRIAL LEAD WARNING FOR LOW IMPEDANCE. THE ATRIAL LEAD REMAINS IN USE PENDING FURTHER EVALUATION AND PENDING A GENERATOR CHANGE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252062 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4511

    Patients

    Seq Age Sex Outcome Treatment
    1