BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL TR

    MDR report key: 2780172 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12324
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    April 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEAD REMAIN IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED REVEALED THAT ALL THE SEAL PLUGS WERE MISSING. THE MARKS IN THE HEADER INDICATE THE LV LEAD WAS FULLY INSERTED INTO THE HEADER.THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS LEFT VENTRICULAR (LV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED LOSS OF CAPTURE AND HIGH IMPEDANCES ON THE LEFT VENTRICULAR CHANNEL WHEN PROGRAMMED USING THE LV TIP ELECTRODE. A CHEST X-RAY WAS PERFORMED AND REVEALED THAT THE LEAD HAD NOT MOVED. IN ADDITION, SATISFACTORY PARAMETERS WERE OBTAINED WHEN EITHER THE TIP OR RING WERE NOT INCLUDED IN THE PROGRAMMING VECTOR. A BOSTON SCIENTIFIC TECHNICAL SERVICE CONSULTANT REVIEWED THIS EVENT AND DISCUSSED THAT THESE OUT OF RANGE MEASUREMENTS COULD BE AN INDICATION OF A LEAD MECHANICAL ISSUE INVOLVING THE LEAD TIP CONDUCTOR OR THE CONNECTOR. IN ADDITION, THE DEVICE SETSCREW OF THE LEAD TIP MAY NOT BE FULLY TIGHTENED. IT WAS THEN SUSPECTED THAT THE LV LEAD HAD MOVED IN THE HEADER OF THE DEVICE, CAUSING OUT OF RANGE MEASUREMENTS IN CERTAIN PROGRAMMED VECTORS. THE DECISION WAS MADE TO LEAVE THE LEAD AND DEVICE IMPLANTED PROGRAMMED WITH AN OPTIMAL VECTOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PRODUCT WAS LATER EXPLANTED AND RETURNED FOR AN UNSPECIFIED REASON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1