BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1852699 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14525
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED POCKET EROSION. THE PATIENT WAS PLACED ON ANTIBIOTICS FOR 14 DAYS AND AFTER THOSE 14 DAYS, THE POCKET WAS REVISED AND CULTURES WERE TAKEN. THE CULTURES CAME BACK NEGATIVE FOR INFECTION. ADDITIONALLY, UPON POCKET OPENING, THE LEADS WERE FOUND TO BE KNOTTED UP IN THE POCKET. THE PATIENT WAS BELIEVED TO HAVE TWIDDLER'S SYNDROME. A NEW CRT-D WAS PLACED AND ALL THE LEADS WERE LEFT IN THE SYSTEM. NO ADVERSE PATIENT 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 H170

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention N119| H170| 0185| 4087| 4549