BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1853918 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-17260
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A COMPETITIVE FIELD REPRESENTATIVE (FR) THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) UNDERWENT A LEFT VENTRICULAR (LV) LEAD REVISION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTIES GETTING THE LV AND RIGHT ATRIAL (RA) SETSCREWS LOOSE. A TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED SOME TROUBLE SHOOTING IDEAS WITH THE FR. THE OUTCOME OF THE CASE IS UNKNOWN AT THIS TIME. AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 H210

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 0158| H210| 4470| 4543