BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOGEN

    MDR report key: 4132248 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15402
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ICD REMAINS IMPLANTED AND IN SERVICE. 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 RIGHT ATRIAL (RA) LEAD, THE LEAD WAS FIRST TESTED ON THE PACING SYSTEM ANALYZER (PSA) AFTER BEING POSITIONED. THE PACING IMPEDANCE MEASUREMENT WAS 500 OHMS AND THE PACING THRESHOLD VALUE WAS AT 0.4 VOLTS. THE RA LEAD WAS THEN CONNECTED TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE MEASUREMENTS WERE REPEATED. THE PACING IMPEDANCE MEASUREMENTS WERE ABOVE 3,000 OHMS AND THERE WAS NO CAPTURE. THE RA LEAD WAS DISCONNECTED AND TESTED AGAIN ON THE PSA BUT THE RESULTS WERE THE SAME. THERE WERE NO ISSUES INSERTING THE RA LEAD TERMINAL PIN INTO THE HEADER. IN ADDITION, THERE WERE NO ANOMALIES NOTED WITH THE RA LEAD UNDER FLUOROSCOPY. THE PHYSICIAN DECIDED TO EXTRACT THIS RA LEAD AND REPLACE IT WITH A NEW ONE OF THE SAME MODEL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613127 AUTOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND D176

    Patients

    Seq Age Sex Outcome Treatment
    1 D176| 7742| 0692