BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1871241 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-19103
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D WAS SUCCESSFULLY REPLACED, BUT IT IS UNKNOWN WHETHER THIS DEVICE WILL BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME, THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT WENT TO THE HOSPITAL DUE TO HEARING BEEPING TONES. DURING INTERROGATION, THE PHYSICIAN NOTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A SHOCK IMPEDANCE VALUE OF LESS THAN 20 OHMS. THE PHYSICIAN WILL DECIDE HOW TO PRECEDE IN THE FUTURE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT A LEAD REVISION PROCEDURE TOOK PLACE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THIS CRT-D. IT WAS NOTED THAT THERE WAS SERUM IN THE DEVICE POCKET. THERE WERE NO LESIONS ON THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD, AND ALL CONNECTIONS WERE GOOD. AFTER THE REPLACEMENT, SHOCK IMPEDANCE VALUES WERE BETWEEN 52-56 OHMS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND M170

    Patients

    Seq Age Sex Outcome Treatment
    1