BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4163141 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01252
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-1661-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, RETURNED PRODUCT TESTING FOUND THE DEVICE DID PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, AS A RESULT THE MAIN PRINTED CIRCUIT BOARD (PCB) AND FLEX ASSEMBLIES WERE REPLACED. IT WAS ALSO NOTED THAT THERE WAS A CRACK ON A DIAL KNOB AND THERE WAS BLOOD CONTAMINATION ON THE HOUSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACING RATE ON THE EXTERNAL PULSE GENERATOR (EPG) DID NOT MATCH THE PROGRAMMED RATE, PACING AT A LOWER RATE THAN THE SETTING. THE EPG WAS RETURNED TO THE MANUFACTURER FOR SERVICING. THE CONDITION WAS FOUND PRIOR TO BEING USED ON THE PATIENT, NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644186 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5348XW

    Patients

    Seq Age Sex Outcome Treatment
    1