BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE

    MDR report key: 2052845 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03574
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    January 13, 2005
    Report Date
    February 25, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES SUGGESTED MONITORING THE LEAD MORE INTENSELY AS WELL AS TO CHECK THE LEAD IN UNIPOLAR MODE TO SEE IF THERE IS ANY DIFFERENCE. THE CALLER MAY ATTEMPT TO TEST THE LEAD IN UNIPOLAR PRIOR TO THE PATIENT LEAVING. NO FURTHER INFORMATION AVAILABLE. THIS EVENT WILL BE REOPENED SHOULD MORE INFORMATION BE MADE AVAILABLE. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION CONFIRMED THAT THE LEAD WAS RETURNED SEVERED 70MM FROM THE TERMINAL PIN, AND THE PROXIMAL SEGMENT ONLY WAS RETURNED. THE CATHODE COIL IS EXTREMELY STRETCHED AND EXTENDS TO 88MM. THE ANODE COIL IS EXTREMELY STRETCHED AND EXTENDS TO 77MM. THE ENDS OF THE COILS APPEAR CUT AND/OR FRACTURED, MOST LIKELY PULLED TO THE POINT OF FRACTURE. THERE WERE SET SCREW MARKS WERE NOTED ON BOTH TERMINALS, 2 ON EACH.

    Description of Event or Problem · 1

    GUIDANT RECEIVED INFORMATION THAT THE PACEMAKER HAS A BATTERY VOLTAGE INDICATIVE OF REPLACEMENT TIME. THE VENTRICULAR LEAD HAS A BIPOLAR IMMPEDANCE LESS THAN 300 OHMS. THE THRESHOLDS AND SENSING ARE GOOD. NEW INFORMATION WAS RECIEVED THAT THIS LEAD WAS REMOVED FROM SERVICE AND RETURNED TO BOSTON SCIENTIFIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 430-10-58

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR (B)(4)| (B)(4)| (B)(4)