BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXTEND II

    MDR report key: 3212959 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09627
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 17, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    NOTAPVD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS CONFIRMED THE INNER CONDUCTOR COIL WAS FRACTURED 20 MM FROM THE TERMINAL PIN. DETAILED ANALYSIS OF THE FRACTURE SITE DETERMINED THE CONDUCTOR COIL WAS FRACTURED DUE TO CYCLIC FATIGUE AND CONFIRMED HIGH RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCES. THE LOCATION OF THE DAMAGE SITE SUGGESTS THE FRACTURE WAS A RESULT OF STRESS DUE TO THE SUTURE SLEEVE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP THIS RIGHT VENTRICULAR (RV) LEAD REVEALED HIGH PACING IMPEDANCES GREATER THAN 2,000 OHMS. AT THE TIME, ALL MEASUREMENTS WERE CONFIRMED NORMAL AND WITHIN RANGE. THE DECISION WAS MADE TO REMOVE THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD WAS RETURNED FOR ANALYSIS WITH NO ORIGINAL ALLEGATIONS OF MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312380 FLEXTEND II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4097

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening F051| 0185| 1860| 0175| 4097