BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTAK RENEWAL 4 IS-1/DF-1/IS-1

    MDR report key: 1683429 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-02636
    Event Type
    Other
    Date Received
    May 7, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AFTER IMPLANTING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PERFORMING INDUCTION TESTING AT MAXIMUM ENERGY DID NOT CONVERT THIS PATIENT INDUCED ARRHYTHMIA. THE PHYSICIAN USED EXTERNAL DEFIBRILLATION IN ORDER TO CONVERT THE PATIENT BACK TO A NORMAL RHYTHM. ANOTHER PROCEDURE IS SCHEDULED TO IMPLANT A HIGH ENERGY DEVICE. THE PHYSICIAN CONFIRMED THAT THERE WAS NO DEVICE MALFUNCTION AND THE PATIENT NEEDED A HIGH ENERGY DEVICE DUE TO A PATIENT RELATED CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 4 IS-1/DF-1/IS-1 IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190 NA

    Patients

    Seq Age Sex Outcome Treatment
    1