BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE II STEROX

    MDR report key: 1944891 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19492
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    October 4, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RA LEAD WAS EXPLANTED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE THE LEAD HAS BEEN RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, THE LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION OF THE ELECTRODE END FOUND THAT THE HELIX IS WITHIN SPECIFICATION AND ALL FOUR TINES WERE INTACT. THE HELIX MECHANISM WAS TESTED AND WAS FOUND TO BE OPERATING NORMALLY. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE OUT OF RANGE PACING IMPEDANCES OBSERVED DURING THE IMPLANT PROCEDURE. THE LEAD WAS FOUND TO BE ELECTRICALLY CONTINUOUS WITH NO EVIDENCE OF A FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT WHEN THIS RIGHT ATRIAL (RA) LEAD WAS POSITIONED DURING THE IMPLANTATION PROCEDURE, IT WAS NOTED THAT THE PACING IMPEDANCE MEASUREMENT WAS ABOVE 3000 OHMS WHEN MEASURED ON THE PACING SYSTEM ANALYZER (PSA). THE LEAD WAS REPOSITIONED SEVERAL TIMES, NEW CLIPS AND PSA CABLES WERE USED, BUT THE IMPEDANCE MEASUREMENT WAS STILL ABOVE 3000 OHMS. IT WAS SUSPECTED THAT THIS LEAD WAS FRACTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II STEROX IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other