BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 3992692 · Received August 8, 2014

    Report

    Report Number
    6000030-2014-00114
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 22, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 PATIENT¿S DEVICE WAS REPROGRAMMED DUE TO AN IRREGULAR HEARTBEAT. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469462 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY RICE CREEK MFG MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention