BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3241476 · Received July 22, 2013

    Report

    Report Number
    2124215-2013-11651
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO VENTRICULAR TACHYCARDIA MODE OTHER THAN MONITOR PLUS THERAPY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REASON OF DEACTIVATION WERE UNSUCCESSFUL. THE DEVICE DID NOT PROVIDE A TACHY THERAPY. THIS DEVICE REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340067 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H219

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR H219| 0184| 4470| 4518