BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1871121 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17229
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 25, 2010
    Report Date
    December 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS LEAD WAS SURGICALLY ABANDONED; THEREFORE, THE COMPANY WILL BE UNABLE TO PERFORM ANALYSIS ON THIS LEAD. SHOULD IT BE RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A LEAD SAFETY SWITCH OCCURRED ON THIS RIGHT VENTRICULAR LEAD. AT THIS PATIENTS LAST DEVICE CHECK 7 MONTHS AGO THE LEAD IMPEDANCE MEASUREMENTS WERE APPROXIMATELY 1400 OHMS. AFTER THE SWITCH OCCURRED THE DAILY MEASUREMENT READINGS HAVE BEEN BETWEEN 300-350 OHMS. TECHNICAL SERVICES WAS CONSULTED AND SUGGESTED RESETTING THE SWITCH AND TESTING THE IMPEDANCE IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS WHILE DOING POCKET MANIPULATIONS AND TESTING FOR NOISE. SINCE THIS PATIENT ONLY PACES IN THE ATRIUM, AND THE DEVICE IS CLOSE TO REPLACEMENT TIME, THE DECISION WAS MADE TO LEAVE THE LEAD IN FOR NOW AND KEEP AN EYE ON IT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT THIS PATIENT EXHIBITED SOME INSTANCES OF STORED VENTRICULAR TACHYCARDIA EVENTS AS WELL AS NOISE IN THE ARRHYTHMIA LOGBOOK ON BOTH THE VENTRICULAR AND ATRIAL LEADS. THERE IS STILL EVIDENCE OF OUT OF RANGE AND FLUCTUATING IMPEDANCES OF GREATER THAN 2500 OHMS TO 1900 OHMS. IT IS THOUGHT THAT THERE MIGHT BE SOME EXTERNAL ELECTROMAGNETIC INTERFERENCE CAUSING THESE MEASUREMENTS. THE PATIENT IS ASYMPTOMATIC AND BOTH LEADS REMAIN IMPLANTED AT THIS TIME.

    Description of Event or Problem · 1

    NEW INFORMATION BECAME AVAILABLE DURING THE MOST RECENT DEVICE CHANGE OUT PROCEDURE, THIS LEAD WAS STILL EXHIBITING PACING IMPEDANCES OF GREATER THAN 2500 OHMS, AS WELL AS LOSS OF CAPTURE AT MAX OUTPUTS IN THE BIPOLAR CONFIGURATION. AS A RESULT, IT WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4458

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)