BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2052879 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03785
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    May 28, 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

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THIS PATIENT WAS HOSPITALIZATION AND INTUBATED FOR AN UNKNOWN REASON. THE FIELD REPRESENTATIVE INDICATED THEY COULD NOT PERFORM VALSALVA MANEUVERS DUE TO THE PATIENT'S CONDITION, AND DIAPHRAGMATIC OVERSENSING WAS SUSPECTED. THERE IS INHIBITION OF PACING GREATER THAN 2 SECONDS NOTED. ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. ATRIAL THRESHOLD MEASUREMENTS WERE .8 VOLTS AT .5 MILLISECOND, THE RV WAS .8V AT .5 MILLISECOND AND THE LV WAS 1V AT .5 MILLISECOND. THE SENSITIVITY WAS CHANGED FROM NOMINAL TO LEASTAND DEFIBRILLATION TESTS WERE DONE IN LEAST. THERE WERE NO ALLEGATION AGAINST THE DEVICE REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED NOISE ON THE RIGHT VENTRICULAR (RV) RATE/SENSE CHANNEL. THERE WERE THREE NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES RECORDED AS A RESULT OF THE NOISE. THE FIELD REPRESENTATIVE WAS ABLE TO REPRODUCE THE NOISE WHEN THE PATIENT BARED DOWN. THERE WAS PACING INHIBITION GREATER THAN 2 SECONDS RECORDED. THE PHYSICIAN DECIDED TO MONITOR THE PATIENT AS THE PATIENT HAS NO SYMPTOMS ASSOCIATED WITH THE OVERSENSING. 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 82 YR H210| 4518| 0185| 4046| 4470| 4047