BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3721483 · Received April 2, 2014

    Report

    Report Number
    2124215-2014-03262
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    March 1, 2013
    Report Date
    February 19, 2014
    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, THE LEAD WAS RETURNED AND CAREFULLY EXAMINED. VISUAL INSPECTION REVEALED THAT THE LEAD WAS SEVERED 90 MILLIMETERS FROM THE TERMINAL PIN. THE HELIX WAS RETRACTED AND INSULATION WAS STRETCHED BETWEEN THE ANODE ELECTRODE AND THE HELIX HOUSING. ALSO, THE LEAD TIP WAS BENT BETWEEN THE HELIX HOUSING AND ANODE RING AT A 90 DEGREE ANGLE. DRIED BLOOD WAS NOTED THROUGH THE ENTIRE LEAD. THE EXTRACTION STYLET WAS RETURNED STUCK IN THE DISTAL SEGMENT OF THE LEAD DUE TO EXPLANT OF THE LEAD. THE DEFORMED CONDUCTOR COILS 85 MILLIMETERS (MM) FROM THE TERMINAL PIN WAS MOST LIKELY DUE TO THE TIE DOWN OF THE SUTURE SLEEVE. THERE WERE ALSO CUTS IN THE INSULATION 185-188, 200, 379, 440-460 AND 465 MM FROM THE TERMINAL PIN DUE TO THE LASER EXTRACTION OF THE LEAD. IT WAS CONCLUDED THAT THE DAMAGE NOTED DURING VISUAL INSPECTION WAS FIELD INDUCED. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD EXHIBITED FLUCTUATING IMPEDANCE MEASUREMENTS FROM 1850 OHMS TO LESS THAN 200 OHMS ALONG WITH HIGH PACING THRESHOLDS. AS LEAD FRACTURE WAS SUSPECTED, THE LEAD WAS EXTRACTED AND REPLACED WITH GOOD AND STABLE ELECTRICAL PARAMETERS. THE DEVICE WAS EXPLANTED AS WELL AS IT WAS NEARING ELECTIVE REPLACEMENT INDICATOR (ERI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197750 FLEXTEND II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4096

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 0148| T165| 4096