BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CHAMBER TEMPORARY PACEMAKER

    MDR report key: 2951601 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00023
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 14, 2012
    Report Date
    February 24, 2022
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 THE EXTERNAL PULSE GENERATOR (EPG) DISPLAYED AN ERROR CODE AT POWER UP AND THE LOWER DISPLAY WOULD NOT COME ON DESPITE REPLACING THE BATTERY. TECHNICAL SUPPORT (TS) HAD THE CALLER TRY TO DUPLICATE THE ERROR, HOWEVER THE CALLER COULD NOT DUPLICATE THE ERROR. TS HAD THE CALLER MEASURE THE VOLTAGE OF THE NEW BATTERY AND IT WAS CONSIDERED LOW BATTERY VOLTAGE. TS SUGGESTED THAT THE BIOMEDICAL ENGINEER TO USE AND MEASURE THE VOLTAGE OF ANOTHER BATTERY. TS EXPLAINED THAT SCROLLING OF THE LOWER DISPLAY WAS NORMAL DURING POWER UP AND AFTER POWER UP, THE LOWER DISPLAY WAS BLANK AND PRESSING THE MENU KEY TO ACTIVATE THE LOWER DISPLAY. THE EPG WAS RESTORED TO SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55553 DUAL CHAMBER TEMPORARY PACEMAKER IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown