BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3131179 · Received May 5, 2006

    Report

    Report Number
    3015876-2006-00136
    Event Type
    Malfunction
    Date Received
    May 5, 2006
    Manufacturer
    MEDTRONIC EMERGENCY RESPONSE SYSTEM
    Product Code
    LDD
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC EVALUATED THE DEVICE. PROPER OPERATION WAS OBSERVED DURING FUNCTIONAL AND PERFORMANCE TESTING. THE REPORTED PROBLEM WAS NOT DUPLICATED OR CONFIRMED. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS NOT DETERMINED. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK