BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3993319 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02321
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 18, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL FOR A MONITOR CHECK AND DURING THE CHECK THEY FOUND THAT THE PATIENT HAD A LOW HEART RATE OF 38 PER MINUTE DURING NIGHT. THE PATIENT REPORTED THE EVENT TO HOTLINE AND ASKED FOR A PROGRAMMING CHECK, TO CONFIRM IF THE DEVICE IS PACING. CURRENTLY NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470358 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR