BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET TIP

    MDR report key: 2955122 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01011
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    June 1, 2012
    Report Date
    November 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K894040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD WARNING DUE TO LOW IMPEDANCE. THE PATIENT WILL BE BROUGHT INFOR FURTHER EVALUATION. THE LEAD REMAINS IN USE. NO COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58871 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4081-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR ADSR01 IMPLANTABLE PULSE GENERATOR (IPG)