BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3864660 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00887
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MEDTRONIC MILACA,INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONTROL KNOBS WOULD NOT ADJUST ANYTHING AND AN ERROR MESSAGE WAS DISPLAYED ON THE EXTERNAL PULSE GENERATOR (EPG). TECHNICAL SUPPORT (TS) HAD THE CALLER MEASURE THE 9 VOLT BATTERY VOLTAGE. THE BATTERY VOLTAGE MEASURED WAS 6.94 VOLTS. TS ASKED CALLER TO REPLACE THE 9 VOLT BATTERY AND UPON REPLACEMENT, THE DEVICE OPERATED AS DESIGNED. TS EXPLAINED THE ERROR AND POTENTIALLY THAT THIS WAS RELATED TO LOW BATTERY VOLTAGE AND DISCUSSED IMPACT AND FUNCTION OF LOW BATTERY. THE EPG REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341356 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA,INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1