BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212490 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08997
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. INSPECTION OF THE LEAD BODY AND ELECTRODE TIP FOUND NO ANOMALIES. ELECTRICAL TESTING WAS ALSO PERFORMED, AND AGAIN, NO ANOMALIES WERE NOTED. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLDS AND LOSS OF CAPTURE SHORTLY AFTER IMPLANT. THE ISSUE WAS SUSPECTED TO BE THE RESULT OF DISLODGEMENT DUE TO A LACK OF SLACK LEFT IN THE LEAD. THE PATIENT REPORTED FEELING DIZZY AND LIGHTHEADED WITH A HEART RATE IN THE 30'S. A REVISION PROCEDURE WAS PERFORMED IN WHICH THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT IS NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314391 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R 4034| 4243| 1284| S606