BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3053204 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04513
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 5, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL ANALYSIS REVEALED STRETCHED CONDUCTOR COILS FROM 434-492 MM FROM THE TERMINAL PIN. THE INSULATION IS SEPARATED PROXIMAL TO THE ANODE ELECTRODE. ANALYSIS COULD NOT DETERMINE A MANUFACTURING ISSUE THAT WOULD HAVE CONTRIBUTED TO A LEAD DISLODGEMENT. ELECTRICALLY, THE LEAD MET SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THREE WEEKS POST IMPLANT THIS RIGHT VENTRICULAR LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE. IN ADDITION, THE PATIENT REPORTED EXPERIENCING A SYNCOPAL EPISODE. A FOLLOW UP VISIT WAS PERFORMED AND NO ISSUES WERE REVEALED. IMPEDANCE MEASUREMENTS WERE NORMAL AND THRESHOLD MEASUREMENTS WERE STABLE AT THE SAME IMPLANT MEASUREMENT. MONITORING REVEALED VENTRICULAR PAUSES. IT WAS THOUGHT THIS MAY BE DUE TO THE KINESIOLOGY THERAPY SESSIONS THE PATIENT HAD BEEN RECEIVING WHERE THE PATIENT MOVED THEIR ARMS AND LEGS. THE DEVICE OUTPUTS WERE REPROGRAMMED TO ASSURE PATIENT SAFETY. FINALLY, A DECISION WAS MADE TO REPLACE THE LEAD. DURING THE REVISION PROCEDURE, VISUAL OBSERVATION REVEALED THE LEAD WAS NOT POSITIONED AT THE IMPLANTED POSITION IN THE VENTRICULAR APEX. LEAD DISLODGEMENT WAS SUSPECTED; POSSIBLY DUE TO THE KINESIOLOGY TREATMENTS. RETESTING THE LEAD REVEALED INCREASED VOLTAGES OF 7V WERE NEEDED TO ARCHIVE VENTRICULAR CAPTURE. A DECISION WAS MADE TO REPLACE THIS LEAD. THIS LEAD WAS REMOVED AND REPLACED AT THE APEX POSITION. ACCEPTABLE MEASUREMENTS WERE OBTAINED POST REVISION.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154424 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R