BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 2954600 · Received February 11, 2013

    Report

    Report Number
    2183613-2013-00213
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 4, 2012
    Report Date
    November 4, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: (B)(4): THE EPG WAS SENT FOR SERVICE AND ANALYSIS FOUND NO ANOMALIES. THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS CONNECTED TO THE PATIENT. WHILE THE PATIENT WAS BEING TAKEN TO THE CATHETERIZATION LABORATORY, THE STAFF LOOKED AT THE EPG IN THE CATHETERIZATION LABORATORY, AND IT HAD STOPPED. THE EPG WAS TURNED BACK ON, AND IT RESTARTED. THE PATIENT DID NOT HAVE ANY HEALTH HAZARDS, BECAUSE THE PATIENT HAD OWN HEARTBEAT; ABOUT 35BPM. THE PATIENT WAS IMPLANTED A PERMANENT PACEMAKER IN THE CATHETERIZATION LABORATORY. THE EPG WAS SENT FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS CONNECTED TO THE PATIENT. WHILE THE PATIENT WAS BEING TAKEN TO THE CATHETERIZATION LABORATORY, THE STAFF LOOKED AT THE EPG IN THE CATHETERIZATION LABORATORY, AND IT HAD STOPPED. THE EPG WAS TURNED BACK ON, AND IT RESTARTED. THE PATIENT DID NOT HAVE ANY HEALTH HAZARDS, BECAUSE THE PATIENT HAD OWN HEARTBEAT; ABOUT 35BPM. THE PATIENT WAS IMPLANTED A PERMANENT PACEMAKER IN THE CATHETERIZATION LABORATORY. THE EPG WAS SENT FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58133 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC MILACA, INC. MEP3000EN

    Patients

    Seq Age Sex Outcome Treatment
    1