BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2911808 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17031
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    August 3, 2012
    Report Date
    December 5, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC THREE WEEKS AFTER THE SYSTEM EXTRACTION AND REPLACEMENT PROCEDURE. THE PATIENT WAS ASYMPTOMATIC, AND THE NEW SYSTEM WAS PACING AND SENSING APPROPRIATELY. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. AN AMENDED REPORT WILL BE SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) PACING LEAD WAS IMPLANTED AFTER THE PATIENT PRESENTED TO THE HOSPITAL WITH NAUSEA AND DIZZINESS. THERE WAS EVIDENCE OF VENTRICULAR NON-CAPTURE WITH THE COMPETITIVE RV LEAD. THE COMPETITIVE RV LEAD WAS SURGICALLY ABANDONED AND THIS LEAD WAS IMPLANTED. DURING THE PROCEDURE, THE CHRONIC PACEMAKER WAS REPLACED AS IT WAS NEARING THE REPLACEMENT TIME. THREE HOURS POST-OPERATION, THE PATIENT EXPERIENCED FURTHER NAUSEA AND DIZZINESS. A SIX-SECOND PAUSE IN PACING, WITH LOSS OF CAPTURE, WAS REPORTED. NO PACING PAUSES COULD BE REPRODUCED, AND DEVICE INTERROGATION DID NOT REVEAL ANY ISSUES. AT THIS TIME, IT WAS NOTED THAT THE CHRONIC, COMPETITIVE RIGHT ATRIAL (RA) LEAD ALSO EXHIBITED LOSS OF CAPTURE AND LOSS OF SENSING. THE DEVICE WAS REPROGRAMMED TO VVIR MODE AND THE PATIENT WAS REFERRED FOR LASER LEAD EXTRACTION AT ANOTHER FACILITY. THREE MONTHS LATER, THE COMPETITIVE RA LEAD, THE CAPPED COMPETITIVE RV LEAD, AND THIS ACTIVE BOSTON SCIENTIFIC RV LEAD WERE ALL EXTRACTED. THE PACEMAKER WAS ALSO REPLACED TO REDUCE THE CHANCE OF INFECTION. NEW BOSTON SCIENTIFIC RA AND RV PACING LEADS WERE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXTRACTED LEADS WERE NOT PLANNED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18829 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 0982| S602| 0976| 1388T| 1346T| 4471