BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2172875 · Received July 22, 2011

    Report

    Report Number
    2124215-2011-10269
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RV LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP VISIT OF THE PATIENT'S PACEMAKER, IT WAS NOTED THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD COMPLETELY DISLODGED AS THERE WAS NO CAPTURE AND HIGH THRESHOLDS. THIS PATIENT HAD A GOOD UNDERLYING RHYTHM AND CURRENTLY WAS NOT USING THE DEVICE FOR PACING PURPOSES. DUE TO THE PATIENT'S AGE, THE DECISION WAS MADE TO LEAVE THE LEAD IMPLANTED AND A REVISION PROCEDURE MAYBE PERFORMED AT A LATER DATE. NO ADVERSE PATIENT EFFECTS 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 Other