BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 4161086 · Received October 10, 2014

    Report

    Report Number
    2183613-2014-01173
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT; DEVICE PASSED ALL FUNCTIONAL TESTS. ANALYSIS FOUND THE LOWER CASE AND ONE BAIL COVER ARE BROKEN. UPPER CASE IS DENTED IN ONE CORNER AND THE RING IS BENT. IT IS NOTED THE BATTERY RECEIVED WITH DEVICE MEASURED 8.26 VOLTS NO LOAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LOWER RATE WAS SET @ 40 PPM (PULSES PER MINUTE) AND THE DEVICE PACED @ 60 PPM. THE DEVICE WAS RETURNED FOR REPAIR AND CALIBRATION. IT IS NOTED THE PATIENT WAS STABILIZED WITH NO HARM DONE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642531 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1