BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 2060167 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05802
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF FURTHER INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT FOLLOWING SUCCESSFUL DEVICE IMPLANT, THE PHYSICIAN REPORTEDLY WAS UNABLE TO ESTABLISH TELEMETRY. ADDITIONALLY, IMMEDIATELY POST IMPLANT, NOISE INTERFERENCE AND LOSS OF CAPTURE WERE OBSERVED. THE ASSOCIATED RIGHT VENTRICULAR AND RIGHT ATRIAL CHRONIC LEADS ARE OF ANOTHER MANUFACTURER; HOWEVER, INVOLVED WITH OBSERVED PACING INHIBITION. THE PHYSICIAN CONFIRMED APPROPRIATE LEAD POSITIONING AND MOVED THE PATIENT TO ANOTHER ENVIRONMENT FOR ADDITIONAL SYSTEM EVALUATION. FAVORABLE VALUES WERE RECORDED AND NO ADVERSE PATIENT EFFECTS HAD RESULTED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE IN THE ABSENCE OF ADDITIONAL ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL TR IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND H140

    Patients

    Seq Age Sex Outcome Treatment
    1