BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2170812 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09842
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST OPERATIVE CHECKS THAT BOTH THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS HAD DISLODGED. A REVISION TOOK PLACE AND THE LEADS WERE REPOSITIONED SUCCESSFULLY. THE NEXT DAY ANOTHER FOLLOW UP TOOK PLACE WHICH SHOWED THAT THE RIGHT VENTRICULAR LEAD HAD DISLODGED ONCE AGAIN AND UNDERSENSING, OVERSENSING AND LOSS OF CAPTURE WAS NOTED. DUE TO THE PATIENT ANATOMY A DIFFERENT COMPETITOR LEAD WAS USED. ONCE AGAIN DURING THE FOLLOW UP LOSS OF CAPTURE WAS NOTED, AND A REPOSITIONING PROCEDURE OF THE COMPETITOR RIGHT VENTRICULAR LEAD WAS SCHEDULED. THE PLANNED PROCEDURE WAS CANCELLED DUE TO THE PATIENT BEING UNSTABLE. THE BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD WILL NOT BE RETURNED, WHILE THE RIGHT ATRIAL LEAD AND PACEMAKER REMAIN IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED FOLLOWING THE PROCEDURE.

    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