BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2801800 · Received October 23, 2012

    Report

    Report Number
    2124215-2012-14369
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) UNDERWENT A PROCEDURE IN WHICH A MAGNET WAS APPLIED TO THE DEVICE. AFTER BEING DISCHARGED THE DEVICE BEGAN EMITTING BEEPING TONES. DEVICE INTERROGATION REVEALED A MESSAGE INDICATING THE DEVICE WAS IN THE PRESENCE OF A MAGNET, HOWEVER NO MAGNET WAS PRESENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THIS DEVICE IS INCLUDED IN THE 2010 MAGNETIC REED SWITCH ADVISORY. ENABLE MAGNET USE WAS PROGRAMMED OFF AND PATIENT TRIGGERED MONITOR EGM MODE WAS PROGRAMMED ON AND THEN OFF TO RE-ENABLE DAILY MEASUREMENTS. NO PATIENT SYMPTOMS OR ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H210

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4549| 0185| 4473| H210