BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND

    MDR report key: 2640928 · Received July 5, 2012

    Report

    Report Number
    2124215-2012-06292
    Event Type
    Injury
    Date Received
    July 5, 2012
    Date of Event
    April 4, 2012
    Report Date
    May 24, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR (B)(4) LABORATORY, THE CATHODE CONDUCTOR COIL WAS FOUND TO BE FRACTURED BETWEEN 132-138 MILLIMETERS FROM THE TERMINAL PIN, ALONG WITH SLIGHTLY FLATTENED ANODE CONDUCTOR COILS AND COMPRESSION MARKS ON THE INSIDE CIRCUMFERENCE OF THE OUTER TUBING IN THE AREA BETWEEN 130-145 MILLIMETERS FROM THE TERMINAL PIN. DUE TO THE LOCATION AND TYPE OF DAMAGE, IT APPEARS THIS DAMAGE WAS MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE FIRST RIB REGION.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4087

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4087| 4469| S602