BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3994017 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02280
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMPANY REPRESENTATIVE STATED THAT WHEN AN EXTERNAL PULSE GENERATOR (EPG) WAS TURNED OFF, IT HAD A SELF-TEST ERROR MESSAGE. TECHNICAL SERVICES (TS) PROVIDED ASSISTANCE IN RESOLVING THE ISSUE BY EXPLAINING THE REASON FOR THE ERROR MESSAGE. THE ERROR WAS CLEARED BY REMOVING THE BATTERY AND REINSERTING IT. THE EPG WAS PLACED BACK INTO SERVICE AND REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471782 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1