BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3921686 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13065
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    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

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION WAS PERFORMED. PRODUCT ANALYSIS REVEALED THAT THE ANODE AND CATHODE HAD A FRACTURE APPROXIMATELY 165 MM FROM THE TERMINAL PIN AND 30 MM DISTAL AREA OF SUTURE SLEEVE WAS TIED DOWN. THE TYPE OF FRACTURE IS CONSISTENT WITH FATIGUE FRACTURE. THE LEAD WAS CLINICALLY OUT OF SPECIFICATIONS AND ANALYSIS CONFIRMS THE HIGH OUT-OF-RANGE (OOR) PACING IMPEDANCE OBSERVATION AGAINST THE LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PACEMAKER WITH THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE GREATER THAN 2000 OHMS. THE RV LEAD WAS CUT OFF AND THE LEAD BODY WAS COILED UP IN THE RA. FURTHER, A LEAD EXTRACTION WAS PERFORMED AND RV LEAD WAS CAUGHT FROM THE FEMORAL ACCESS AND REMOVED SUCCESSFULLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE SYSTEM WAS EXPLANTED AND NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400223 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 1290| 4136| 4469| 4135| K174| 4473