BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARELINK

    MDR report key: 3863659 · Received June 10, 2014

    Report

    Report Number
    2182208-2014-01781
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    KRG
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DURING ROUTINE DEVICE INTERROGATION THE EMERGENCY PROGRAMMER BUTTON WAS INADVERTENTLY ACTIVATED BY THE TECHNICIAN PLACING THE PATIENT IN EMERGENCY PACING MODE. THIS MODE OCCURRED FOR APPROXIMATELY THIRTY SECONDS AND THE PATIENT WAS RETURNED TO PREVIOUS SETTINGS. THE PATIENT REPORTED FEELING MUSCLE PAIN AND CHEST PAIN AND FEELING AS IF ¿LARGE AMOUNTS OF ELECTRICITY¿ WAS GIVEN TO THE PATIENT AND FURTHER REPORTED FEELING ¿PAINFUL SHOCKING¿. THE PATIENT ALSO REPORTING CONCERN ABOUT UNKNOWN INJURY TO UNBORN TWINS. ADDITIONAL INFORMATION RELATED TO THE PATIENT CONDITION AND CONDITION OF THE UNBORN TWINS HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337587 CARELINK PROGRAMMER, PACEMAKER KRG MEDTRONIC, INC. 2090

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ADDRL1 IPG