BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1951955 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23071
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    November 24, 2010
    Report Date
    November 29, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-1620-09 TO Z-1621-09
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A STANDARD CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGEOUT PROCEDURE THERE WERE DIFFICULTIES EXPERIENCED WITH LOOSING SETSCREWS. SUBSEQUENTLY THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE IN WHICH THE SETSCREWS WERE DRILLED OUT. THERE WAS NO DAMAGE REPORTED AGAINST THE LEADS AND THEY REMAIN IN-SERVICE. THE PHYSICIAN REQUESTED TO KEEP THE DEVICE TO EDUCATE OTHER PHYSICIANS ON DRILLING TECHNIQUES. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED BESIDES THE ADDITIONAL PROCEDURE TO RESOLVE STUCK SETSCREW ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H179

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 828| 4518| H179| 0185| (B)(4)| (B)(4)