BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE II STEROX

    MDR report key: 3904906 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09630
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS ATRIAL LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS. IN ADDITION, THE IMPEDANCE MEASUREMENTS HAVE INCREASED SINCE THE LAST VISIT. AN X-RAY REVEALED THE LEAD TIP HAD NOT MOVED, HOWEVER THE AREA AROUND THE SUTURE SLEEVE APPEARED PULLED. THE OUTPUT SETTINGS WERE INCREASED. A FOLLOW UP VISIT WILL BE PERFORMED AT A LATER DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385067 THINLINE II STEROX IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4376

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR MISMATCH| 4377| 4376