BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3210127 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07434
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 31, 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 AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. DRIED BLOOD PAST THE HELIX MECHANISM UP THROUGH THE LUMEN. HELIX IS STRETCHED. STYLET WAS RETURNED IN THE LEAD.

    Additional Manufacturer Narrative · 1

    TO DATE, THE EXPLANTED LEAD HAS NOT BEEN RECEIVED AT BOSTON SCIENTIFIC. UPON RECEIPT THE LEAD WILL UNDERGO DETAILED LABORATORY ANALYSIS IN AN ATTEMPT TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP, THIS RIGHT VENTRICULAR (RV) LEAD REVEALED LOW PACING IMPEDANCE LESS THAN 200 OHMS AND NOISE. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REMOVED AND REPLACED. THE NEW LEAD WAS CHECKED AND ALL MEASUREMENTS WERE NORMAL AND WITHIN RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310868 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R