BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE II STEROX

    MDR report key: 2153655 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06244
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    July 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RA LEAD REMAINS IN SERVICE, SO THEREFORE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING FOLLOW-UP, IT WAS OBSERVED THIS RIGHT ATRIAL (RA) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. THE DECISION WAS MADE TO REPROGRAM THIS LEAD FROM BIPOLAR TO UNIPOLAR. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT A FOLLOW-UP WAS PERFORMED. THIS RA LEAD STILL DISPLAYED PACING IMPEDANCE MEASUREMENTS GREATER THAN 3,000 OHMS. PACING DID NOT CAPTURE AT 7.5 VOLTS, AND IT WAS NOT POSSIBLE TO MEASURE THE AMPLITUDE. THERE WERE NO CHANGES MADE TO PROGRAMMING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1