BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3210083 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06993
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED A CUT THROUGH THE INSULATION AT 18.5 CM FROM THE PIN, HOWEVER NO CUT WAS NOTED ON THE SUTURE SLEEVE. DRIED BLOOD WAS NOTED INSIDE THE LEAD; LIKELY INTRODUCED AT THE CUT SITE. THE HELIX AND LEAD TIP REVEALED NO IRREGULARITIES. ANALYSIS COULD NOT DETERMINE ANY MANUFACTURING DEFECT THAT COULD HAVE CONTRIBUTED TO THE LEAD DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY THREE WEEKS POST IMPLANT, THE PATIENT WITH THIS RIGHT VENTRICULAR LEAD EXPERIENCED A PRE-SYNCOPAL EPISODE. INTERROGATION REVEALED INTERMITTENT EXIT BLOCK. IT WAS THOUGHT THIS LEAD HAD DISLODGED OR THERE WAS INSULATION DAMAGE. A REVISION PROCEDURE WAS PERFORMED. THIS LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. UPON REMOVAL, VISUAL INSPECTION DID NOT REVEAL ANY INSULATION DAMAGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311823 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R