BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3212473 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08909
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 28, 2013
    Report Date
    July 29, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE ALLEGATION AGAINST THIS LEAD WAS CONFIRMED. A MICROSCOPIC INSPECTION OF THE LEAD REVEALED A CATHODE COIL FACTURE APPROXIMATELY 18.2 CENTIMETERS FROM THE TERMINAL PIN IN THE AREA OF THE SUTURE SLEEVE TIE-DOWN. THIS TYPE OF FRACTURE IS CONSISTENT WITH A FATIGUE FRACTURE. THE LEAD HAS SINCE BEEN ARCHIVED.

    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 WAS EXPLANTED DUE TO INTERMITTENT LOSS OF CAPTURE (LOC) AND NOT DELIVERING PACING WHEN REQUIRED DUE TO OVERSENSING. THE PATIENT¿S HEART RATE WAS IN THE 30¿S AND THEY CAME INTO THE HOSPITAL WITH SYMPTOMS OF LOSS OF CAPTURE HOWEVER IT IS UNKNOWN HOW LONG THE LOC WAS OR IF THERE WAS ANY ASYSTOLE LASTING GREATER THAN TWO SECONDS. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH ANOTHER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313004 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 4470| 5076| 4471| K063| 1280| 1291