BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991582 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02127
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE NEGATIVE ELECTRODE WAS NOT CONDUCTING. AS A RESULT THE CABLE WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEGATIVE ELECTRODE OF THE PATIENT CABLE WAS NOT CONDUCTING. THE CABLE WAS RETURNED TO THE MANUFACTURER FOR INSPECTION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468893 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5433V

    Patients

    Seq Age Sex Outcome Treatment
    1 5318 EXTERNAL PULSE GENERATOR