BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 2951600 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00041
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 BY THE BIOMEDICAL ENGINEER THAT DURING TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE ATRIAL OUTPUT BECAME INTERMITTENT WHEN MOVING THE TEST LEADS WITHIN THE HEART BLOCK. TECHNICAL SUPPORT (TS) SUGGESTED THAT THE BIOMEDICAL ENGINEER TEST THE DEVICE WITH THE PATIENT CABLE AND THAT IF IT WAS NOT INTERMITTENT, THEN THE ISSUE WOULD BE WITH THE CONTACTS TO THE HEART BLOCK. TS ALSO GAVE THE BIOMEDICAL ENGINEER THE PART NUMBER FOR THE CONTACTS TO THE HEART BLOCK. THE EPG WILL BE SENT IN FOR REPAIR IF THE BIOMEDICAL ENGINEER CANNOT FIX IT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56461 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1