BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2170839 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11053
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    March 31, 2011
    Report Date
    June 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. THE RELATED DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE CONCLUDED THE LEAD WAS THE MOST LIKELY CAUSE OF THE CLINICAL OBSERVATIONS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PRODUCT HAD REPORTED SLOW HEART RATES OF APPROXIMATELY 40 BEATS PER MINUTE (BPM). A HOLTER MONITOR RECORDED SEVERAL PAUSES IN PACING. INTERROGATION OF THE DEVICE NOTED OVERSENSING OF NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL, CAUSING PACING INHIBITION. THE PATIENT HAD AN ESCAPE RHYTHM OF ABOUT 40 BPM. THE DEVICE SENSITIVITY WAS REPROGRAMMED TO ENSURE CONSTANT PACING. A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION, IT WAS NOTED THE DISTAL RV SETSCREW HAD NOT BEEN SEATED. PROPER CONNECTION WAS REESTABLISHED AND THE PROBLEM WAS RESOLVED. FURTHER INFORMATION WAS LATER RECEIVED THAT THE PATIENT HAD PRESENTED WITH AN IRREGULAR RHYTHM DUE TO LOSS OF CAPTURE. THE PACING IMPEDANCE MEASUREMENT WAS GREATER THAN 2500 OHMS IN BIPOLAR PACING MODE. A SECOND REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS ABANDONED AND REPLACED. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

    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 Required Intervention (B)(4)| (B)(4)| (B)(4)