BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3043142 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01926
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS RETURNED FOR LABORATORY ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. 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 DEFORMED CONDUCTOR COILS AT 98 MM FROM THE TERMINAL PIN, LIKELY CAUSED DURING THE EXPLANT PROCEDURE. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATION OF LOSS OF CAPTURE.

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IMPLANTED WITHOUT FURTHER COMPLICATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. THE PATIENT PRESENTED TO THE CLINIC, WHERE INTERMITTENT LOSS OF CAPTURE IN THE RV WAS OBSERVED. THE PATIENT HAD AN UNDERLYING RHYTHM OF 30 BPM. AN X-RAY WAS NON-CONCLUSIVE FOR DISLODGEMENT; HOWEVER, THE PACING THRESHOLD MEASUREMENTS HAD INCREASED AND THE R-WAVE MEASUREMENTS HAD DECREASED. A LEAD REVISION WAS PERFORMED. DURING THE PROCEDURE, THE LEAD INSULATION WAS DAMAGED WHILE USING CAUTERY SO THE LEAD WAS EXPLANTED AND A NEW BOSTON SCIENTIFIC PACING LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DUE TO THE INTERMITTENT LOSS OF CAPTURE. THE EXPLANTED LEAD IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IN POST-IMPLANT RECOVERY, THIS RIGHT VENTRICULAR (RV) LEAD EXPERIENCED LOSS OF CAPTURE, RESULTING IN THE PATIENT EXPERIENCING SEVERAL PAUSES IN PACING OF 2.5 TO 3 SECONDS. NO SYNCOPE OR OTHER ADVERSE PATIENT EFFECTS HAD OCCURRED. PACING THRESHOLDS WERE FOUND TO BE FLUCTUATING BETWEEN 2.5V AND 3.7V AT 0.5MS. THE RV OUTPUT WAS REPROGRAMMED TO 6.0V AT 1.0MS AND THE PATIENT WAS DISCHARGED HOME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147712 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R