BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOGEN

    MDR report key: 3904567 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11764
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    February 28, 2014
    Report Date
    April 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS DEVICE, IT WAS DIFFICULT TO INSERT THE LEFT VENTRICULAR (LV) LEAD INTO THE DEVICE HEADER. THERE APPEARED TO BE A HIGH AMOUNT OF FRICTION BETWEEN THE HEADER AND THE CONNECTOR OF THE LV LEAD. FULL INSERTION WAS ONLY OBTAINED AFTER MINERAL OIL AS APPLIED TO THE TERMINAL PIN; HOWEVER, INSERTION WAS STILL A BIT DIFFICULT. THE DEVICE AND LEAD WERE SUCCESSFULLY IMPLANTED AND REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382351 AUTOGEN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND G179

    Patients

    Seq Age Sex Outcome Treatment
    1 4677| 0696| MISMATCH| G179