BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIVIAN

    MDR report key: 2050636 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03034
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A REVISION PROCEDURE. THE REPRESENTATIVE REPORTED THAT THE RV SETSCREW WAS LOOSE AND THE PHYSICIAN ADMITTED THAT THE SETSCREW MUST NOT HAVE TIGHTENED APPROPRIATELY AT INITIAL IMPLANT. THE LV IMPEDANCES WERE OUT OF RANGE BECAUSE OF EXTENDED BIPOLAR PROGRAMMING. THE SETSCREW WAS TIGHTENED AND VALUES NORMALIZED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A LEAD REVISION. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), LEFT AND RIGHT VENTRICULAR LEADS DEVELOPED FATIGUE. UPON FURTHER INVESTIGATION THE PACING IMPEDANCES ON THESE LEADS WERE GREATER THAN 2000 OHMS. THERE WAS INQUIRY OF A CONNECTION ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H229

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 1298| 4518| 4035| 4087| 0157| 0158| H219| H229