BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEM VR

    MDR report key: 1921389 · Received December 13, 2010

    Report

    Report Number
    2647346-2010-00822
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 4, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P900061/S47
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT THOUGHT HE HEARD THE PATIENT ALERT TONE THIS MORNING. THE DEVICE IS KNOWN TO BE AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND THE ALERT FOR ERI IS TURNED OFF. REVIEW OF THE CARELINK TRANSMISSION DOES NOT SHOW ANY ALERTS TRIGGERING. 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
    1 GEM VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. 7227E ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other 0074 COMPETITOR IMPLANTABLE TACHY LEAD| 0041 COMPETITOR IMPLANTABLE TACHY LEAD| 6836 COMPETITOR IMPLANTABLE PACING LEAD