BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1875083 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-19611
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    August 11, 2010
    Report Date
    May 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, MICROSCOPIC INSPECTION REVEALED BOTH CONDUCTOR COILS (ANODE AND CATHODE) TO BE FRACTURED APPROXIMATELY 21.6 CM FROM THE TERMINAL PIN. THIS TYPE OF FRACTURE IS NOTED TO BE CONSISTENT WITH FATIGUE FRACTURES.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DURING A REVISION PROCEDURE FOR THE RIGHT VENTRICULAR (RV) LEAD, THE PHYSICIAN ATTEMPTED TO LASER LEAD EXTRACT THIS PREVIOUS SURGICALLY ABANDONED RA LEAD. A PORTION OF THIS LEAD WAS REMOVED FROM THE PATIENT AND THE REMAINING PORTION WAS LEFT IN THE SUPERIOR VENA CAVA. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE EXPLANTED PORTION OF THIS LEAD WAS RETURNED TO ALLOW FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT STATED THIS RIGHT ATRIAL (RA) LEAD WAS TAKEN OUT OF SERVICE DUE TO NOISE AND A POSSIBLE FRACTURE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 4470| 0157| 1888TC| 4555| A135| E030| N119