BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2070217 · Received April 27, 2011

    Report

    Report Number
    2124215-2011-07244
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    December 16, 2010
    Report Date
    March 25, 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 DEVICE WAS DISCARDED BY THE HOSPITAL AND WILL NOT BE RETURNED. AS NO FURTHER INFORMATION IS EXPECTED THE INVESTIGATION IS COMPLETED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE EXPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PHYSICIAN REPORTED HAVING ISSUES REMOVING THE DEFIBRILLATION, RIGHT ATRIAL AND LEFT VENTRICULAR LEADS FROM THE HEADER. AS A RESULT, THE PHYSICIAN BROKE THE HEADER TO REMOVE THE LEADS. BLOOD WAS ALSO NOTED IN THE HEADER. IT WAS LATER REPORTED BY THE PATIENT AND CONFIRMED BY THE PHYSICIAN THAT WHEN THE HEADER WAS BROKE TO REMOVE THE LEADS THE PATIENT WENT INTO ASYSTOLE, DURATION WAS NOT KNOWN, AND THIS EXTERNAL PACING. THE FIELD REPRESENTATIVE WAS NOT AWARE OF THIS ISSUE BECAUSE THEY WERE NOT PRESENT AT THIS PROCEDURE.

    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 69 YR Required Intervention 5826| (B)(4)| 4543| H210| 0184| MISMATCH| 4086