BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 3212427 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08155
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 15, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY ANALYZED. THE DEVICE WAS RETURNED WITH THE HEADER SEPARATED FROM THE DEVICE AND BOTH THE RV AND RA LEAD TERMINAL PINS WERE STUCK IN THE CONNECTOR BLOCK AND WERE UNABLE TO BE REMOVED. VISUAL INSPECTION NOTED THAT THE HEX SLOT ON THE RV SETSCREW WAS DAMAGED. ALL SETSCREWS, INCLUDING THE RV SETSCREW, MOVED FREELY AND OPERATED NORMALLY DURING TESTING. FURTHER INSPECTION OF THE RA AND RV TERMINAL BLOCKS FOUND THAT THE CAPTURE WASHERS WERE BENT OUTWARD, INDICATING THAT THE SETSCREWS WERE IN THE UP POSITION (FULLY DISENGAGED). AN X-RAY WAS TAKEN OF THE TERMINAL BLOCKS AND REVEALED THAT THEY WERE CRUSHED IN SUCH A WAY THAT THE LEADS COULD NOT BE REMOVED. LABORATORY ANALYSIS CONCLUDED THAT THE TERMINAL BLOCKS WERE DEFORMED WHEN THE HEADER WAS REMOVED FROM THE DEVICE DURING THE EXPLANT PROCEDURE. THIS DAMAGE THEN RESULTED IN THE DIFFICULTIES OF REMOVING THE RV AND RA LEAD TERMINAL PINS FROM THE HEADER. IN ADDITION, ALTHOUGH EVIDENCE INDICATES EXTERNAL STRESS MAY HAVE BEEN A FACTOR IN THE HEADER BECOMING LOOSE, ANALYSIS NOTED THAT THERE WAS INSUFFICIENT BONDING BETWEEN THE MEDICAL ADHESIVE AND THE TITANIUM CASING. MANUFACTURING ENHANCEMENTS WERE IMPLEMENTED IN 2003 TO MAKE THE BOND MORE ROBUST.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN ELECTIVE REPLACEMENT PROCEDURE, THE IS-1 RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) SETSCREWS OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WERE UNABLE TO BE DISENGAGED. DIFFERENT WRENCHES WERE USED AND THE DEVICE HEADER WAS REMOVED, BUT THE SETSCREWS REMAINED STUCK IN PLACE. AS A RESULT, THE RV AND RA LEADS HAD TO BE CUT AND THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL WHERE THEY ARE CURRENTLY WAITING TO HAVE THE LEAD EXTRACTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED; HOWEVER THE PATIENT WILL REMAIN HOSPITALIZED UNTIL THE LEADS ARE EXTRACTED AND A NEW SYSTEM IS IMPLANTED. THE CRT-D WILL BE RETURNED FOR IMMEDIATE LABORATORY ANALYSIS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314088 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H197

    Patients

    Seq Age Sex Outcome Treatment
    1