BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2042454 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01357
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE LEAD REMAINS IMPLANTED AND IN SERVICE WITHOUT FURTHER REPORTED COMPLICATIONS. IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST A SUCCESSFUL SINGLE CHAMBER IMPLANT, SIGNIFICANT PAUSES IN RIGHT VENTRICULAR PACING WERE EXHIBITED DURING THE POST IMPLANT EVALUATION. PACING PAUSES RESULTED IN PRESYNCOPAL SYMPTOMS AND APPEARED TO BE RELATED TO PATIENT POSITIONING. AN INTERROGATION REVEALED A SLIGHT INCREASE IN THRESHOLD VALUES; HOWEVER, STABLE IMPEDANCE MEASUREMENTS WERE NOTED. WHILE NO SURGICAL INTERVENTION WAS PERFORMED, IT WAS SUSPECTED THE LEAD HAD LOST IT'S INITIAL POSITIONING. THE FOLLOWING MORNING, THE DEVICE WAS AGAIN INTERROGATED, WITH ALL PACING PARAMETERS CONFIRMED CONSISTENT AND NO FURTHER PAUSES IN PACING OBSERVED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENTS UNDERLYING RHYTHM HAD RESUMED AND NO FURTHER INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1