BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2171577 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09901
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 14, 2011
    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 TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED ONLY THE DISTAL TIP CONNECTOR BLOCK PORTION OF THE HEADER WAS RETURNED WITH THE DEVICE TO OUR QUALITY LABORATORY FOR ANALYSIS. THE DISTAL SETSCREW IN THE CONNECTOR BLOCK WAS THOROUGHLY INSPECTED AND TOOL MARKS WERE VISIBLE WITHIN THE CONNECTOR BLOCK. HOWEVER, THERE WAS NO EVIDENCE OF A TORQUE WRENCH PIECE REMAINING INSIDE THE SETSCREW, AND THE SETSCREW MOVED FREELY AND OPERATED NORMALLY. THE REST OF THE DEVICE HEADER WAS NOT RECEIVED AND COULD NOT BE ANALYZED. AS A RESULT, THE SETSCREW ALLEGATION COULD NOT BE CONFIRMED. ANALYSIS CONFIRMED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION AND THE DEVICE HAD RETURNED TO STORAGE MODE AFTER NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATORS. DURING THE PROCEDURE, INTERROGATION REVEALED THIS DEVICE WAS IN STORAGE MODE. THE PHYSICIAN WAS CONCERNED REGARDING WHETHER THIS INDICATED A DEVICE MALFUNCTION. IN ADDITION, VISUAL INSPECTION REVEALED A SET SCREW HAD BEEN SHEARED OFF DURING THE PREVIOUS PROCEDURE AND THE SET SCREW COULD NOT LOOSENED. THERE FORE, THE HEADER WAS REMOVED. THE DEVICE WITH THE SET SCREW WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H199

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention