BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173139 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10462
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 13, 2011
    Report Date
    November 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. MICROSCOPIC VISUAL INSPECTION NOTED THAT THE RV+ AND RA+ SEAL PLUGS WERE MISSING. TOOL MARKS WERE NOTED IN THE DEVICE HEADER SURFACE AND THE HEADER WAS SLIGHTLY LOOSE. A BROKEN WRENCH TIP WAS NOTED IN THE RA+ SETSCREW HEX SLOT. THE RA+ SETSCREW WAS BACKED UP AGAINST THE RETAINER RING. ALL OTHER SEAL PLUGS WERE INTACT AND ALL OTHER SETSCREWS MOVED FREELY AND OPERATING NORMALLY. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO ALLOW FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE CHANGE OUT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED DIFFICULTY WHEN BEING REMOVED FROM THIS CHRONIC DEVICE. IT WAS LATER NOTED THAT THE IMPLANTING PHYSICIAN DID NOT LOOSEN THE BACK RATE/SENSE SET SCREW. NO FURTHER COMPLICATIONS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR H177| 4087| 4047| 0185| H170