BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1950439 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22414
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT A YELLOW SCREEN WAS DISPLAYED ON THE PROGRAMMER FOLLOWING DEVICE INTERROGATION. THE MESSAGE STATED THAT THE DEVICE WAS IN THE PRESENCE OF A MAGNET. THE PROGRAMMER INDICATED THAT THE DEVICE WAS IN MONITOR PLUS THERAPY MODE. TECHNICAL SERVICES INFORMED THE LOCAL REPRESENTATIVE THAT TACHYCARDIA THERAPY WOULD BE INHIBITED IF THE ENABLE MAGNET USE IS PROGRAMMED ON AND THE DEVICE'S REED SWITCH WAS STILL TRIPPED. TECHNICAL SERVICES EXPLAINED THAT THE STUCK REED SWITCH ISSUE CAN BE RESOLVED AND TACHYCARDIA THERAPY RE-ENABLED IF THE ENABLE MAGNET USE FEATURE IS PROGRAMMED OFF. THE LOCAL REPRESENTATIVE INFORMED TECHNICAL SERVICES THAT THE ENABLE MAGNET USE FEATURE WAS PERMANENTLY PROGRAMMED OFF. TECHNICAL SERVICES COMMENTED THAT THE DEVICE MAY EXPERIENCE A SHORTER LONGEVITY DUE TO THE STUCK REED SWITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H215

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening 4524| MISMATCH| H215| 5592| 0175| 5092| 4517