BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 2944585 · Received February 5, 2013

    Report

    Report Number
    2124215-2013-02169
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    August 13, 2012
    Report Date
    August 13, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NKE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. INITIAL ANALYSIS REVEALED THAT THE DEVICE DID NOT HAVE TELEMETRY NOR WAS DEVICE DATA SUFFICIENT TO OBTAIN BATTERY STATUS. THE DEVICE HAD BEEN RETURNED IN ORIGINAL STERILE PACKAGING. A MEMORY DOWNLOAD COULD NOT BE PERFORMED. DETAILED ANALYSIS WAS THEN CONDUCTED. X-RAY EVALUATION WAS PERFORMED. THE TELEMETRY COIL AND BATTERY CONNECTIONS APPEARED TO HAVE NO IRREGULARITIES. MANUAL ELECTRICAL TESTING NOTED NO PACING OUTPUT AND NO TELEMETRY. THE DEVICE CASE WAS REMOVED. ADDITIONAL TESTING WAS ABLE TO ISOLATE THE CAUSE OF THE NO OUTPUT AND NO TELEMETRY TO THE LV POWER INDUCTOR. THE POWER INDUCTOR WAS FOUND TO BE OUT OF SPECIFICATION AND WOULD NOT ALLOW THE POWER SUPPLIES IN THE CIRCUIT TO POWER UP CORRECTLY. THE HYBRID CIRCUIT OPERATED NORMALLY WITH A KNOWN GOOD POWER INDUCTOR SUBSTITUTED INTO THE CIRCUIT. A METALLIC PIECE OF FOREIGN MATERIAL WAS FOUND TO HAVE BEEN IMBEDDED IN THE WINDINGS. THIS FINDING CAUSED THE WINDINGS TO SHORT TOGETHER THAT IN TURN CAUSED THE OUT OF SPECIFICATION CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS ATTEMPTED TO BE INTERROGATED, PRE-IMPLANT, WHILE STILL BOXED. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE DEVICE WAS NOT ABLE TO BE INTERROGATED. A DIFFERENT DEVICE WAS THEN USED FOR IMPLANT. THE CRT-P WAS RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48848 INGENIO IMPLANTABLE CHF GENERATOR NKE GUIDANT CRM CLONMEL IRELAND V173

    Patients

    Seq Age Sex Outcome Treatment
    1