BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 435326 · Received December 27, 2002

    Report

    Report Number
    435326
    Event Type
    Malfunction
    Date Received
    December 27, 2002
    Report Date
    November 25, 2002
    Manufacturer
    MEDTRONIC
    Product Code
    LGW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT HAD AN IMPLANTABLE PULSE GENERATOR SYSTEM PLACED IN 2000. THE PT RETURNED TO WORK ON 1/16/2001. THE PT ENGAGED THE MICROPHONE TO THE BUSINESS RADIO, WHILE AT WORK, AND AN ELECTRO MAGNETIC INTERFERENCE REACTION OCCURRED WHICH RESULTED IN A MALFUNCTION OF THE IMPLANTABLE PULSE GENERATOR SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC IMPLANTABLE PULSE GENERATOR SYSTEM LGW MEDTRONIC LEAD 3887 *
    2 MEDTRONIC IMPLANTABLE PULSE GENERATOR SYSTEM LGW MEDTRONIC EXTENSION 7495-25 *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other