BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860835 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01448
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE CABLE WAS FOUND TO BE FRACTURED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PACING FAILURE WAS FOUND WHEN USING THE EXTERNAL PULSE GENERATOR (EPG), SO A CHECKUP REQUEST WAS RECEIVED FOR THE PATIENT CABLE ASSOCIATED WITH THE EPG. THE CABLE WAS RETURNED TO THE MANUFACTURER. THE PATIENT HAD AN INTRINSIC HEARTBEAT SO THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338009 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5433A

    Patients

    Seq Age Sex Outcome Treatment
    1