BEUDAMED
    FDA Adverse Event Summary report: N

    NONE

    MDR report key: 3131269 · Received May 5, 2006

    Report

    Report Number
    3131269
    Date Received
    May 5, 2006
    Date of Event
    October 29, 2005
    Report Date
    April 17, 2006
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MEDWATCH REPORT WAS RECEIVED WITH THE FOLLOWING EVENT DESCRIPTION: "PATIENT ARRESTED. ATTACHED AED AND UNABLE TO OBTAIN A RHYTHM." THE PT WAS NOT RESUSCITATED. THE RISK MANAGER INDICATED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PT'S OUTCOME. THIS OPINION WAS BASED ON AN ASSESSMENT OF THE PT'S CONDITION. MFR 3015876-2006-00136.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE LDD MEDTRONIC EMERGENCY RESPONSE SYSTEMS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SHOCK ADVISORY ADAPTER