BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3905542 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12450
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 16, 2014
    Report Date
    March 13, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A LEAD REVISION WAS SUBSEQUENTLY PERFORMED AND THE LEAD WAS REMOVED FROM SERVICE AND REPLACED. IT WAS SURGICALLY ABANDONED IN THE PATIENT AND WILL NOT BE RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION CONFIRMED THE LEAD HAD BEEN SEVERED IN THREE SEGMENTS AT 16 CM AND 42 CM FROM IS-1 TERMINAL PIN. ADDITIONALLY, AN INSULATION ABRASION WAS IDENTIFIED. ELECTRICALLY, THE LEAD SEGMENTS WERE FOUND TO BE ELECTRICALLY CONTINUOUS. DETAILED ANALYSIS DETERMINED THE ABRASION MOST LIKELY DUE TO LEAD-ON-LEAD CONTACT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL DETAILS ARE RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM WAS EXHIBITING NOISE ON THE RIGHT VENTRICULAR (RV) SHOCKING CHANNEL WITH LOW SHOCKING IMPEDANCE MEASUREMENTS. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING WAS PERFORMED. HOWEVER, WHEN THE DEVICE BEGAN TO DELIVER A SHOCK, THE LEAD SHORTED DUE TO AN INSULATION BREACH AND THE DEVICE WAS DAMAGED. THE PATIENT WAS CONVERTED BUT THE CALLER WAS UNCERTAIN IF IT WAS DUE TO THE SHOCK OR IF THE PATIENT CONVERTED ON HIS OWN. THE REPRESENTATIVE FROM THE COMPETITIVE DEVICE COMPANY AND THE PHYSICIAN WERE UNABLE TO COMPLETE NIPS EVALUATION. THE PATIENT WAS SENT HOME WITH A LIFEVEST PENDING FULL SYSTEM EXTRACTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383766 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0144

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| O 1851| MISMATCH| 0144| 4271| A155