BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 6475553 · Received April 10, 2017

    Report

    Report Number
    2124215-2017-02320
    Event Type
    Injury
    Date Received
    April 10, 2017
    Date of Event
    January 4, 2017
    Report Date
    January 10, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. A VISUAL INSPECTED NOTED THE CONDUCTOR COILS WERE DEFORMED AT APPROXIMATELY 138-142 MILLIMETERS (MM) AND 170-175 MM FROM THE TERMINAL PIN. CUTS WERE ALSO NOTED IN THE INSULATION AT 143MM, 170-175 MM, AND 192-195 MM FROM THE TERMINAL PIN. THIS DAMAGE OBSERVED WAS THOUGHT TO HAVE BEEN INDUCED DURING THE EXPLANT PROCEDURE. THE LEAD WAS ELECTRICALLY CONTINUOUS AND ANALYSIS WAS UNABLE TO DETERMINE WHY THERE WAS A PACING FAILURE WITH THIS LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST-IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED FROM THE PATIENT AS IT WOULD NOT PACE PROPERLY CAUSING THE PATIENT TO BE IN EXIT BLOCK. DURING REMOVAL, THE PHYSICIAN DAMAGED PART OF THE RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258531 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4459

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4459| 7741| S702