BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1990732 · Received February 15, 2011

    Report

    Report Number
    2183613-2011-00019
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 22, 2010
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    NONE
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EXTERNAL PULSE GENERATOR WAS CONNECTED TO THE PATIENT THAT IT WAS PACING AT A RATE LOWER THAN THE SET RATE. THE DEVICE WAS CHECKED FOR REPAIR AND IT WAS FOUND THAT THE SENSITIVITY SETTING WAS OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5375 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other