BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921773 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-10732
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 21, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED THAT THE LEAD WAS RETURNED SEVERED WITH CUTS NOTED IN THE LEAD INSULATION AND DEFORMED CONDUCTOR COILS. THE EXPANDED POLY PORTION OF THE LEAD WAS TORN AND MOST OF IT WAS MISSING FROM THE DISTAL SPRING ELECTRODE AS IT WAS NOT RETURNED. THE DAMAGED WAS LIKELY RELATED TO THE LASER EXTRACTION PROCESS. DETAILED ANALYSIS OF THE LEAD INDICATED THAT TRILUMEN INSULATION ABRASION WAS NOTED. DUE TO THE LOCATION AND TYPE OF DAMAGED, THIS WAS LIKELY CAUSED BY LEAD-ON-LEAD CONTACT COUPLED WITH MOVEMENT WITHIN THE HEART.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT VENTRICULAR (RV) LEAD AND A COMPETITOR'S TACHY LEAD EXHIBITED LOSS OF CAPTURE (LOC) AT MAXIMUM OUTPUT. A DECREASING IMPEDANCE MEASUREMENT WAS ALSO NOTED. THE CAUSE OF OBSERVATION WAS NOT DETERMINED AND NO ASYSTOLE WAS OBSERVED. THE DEVICE AND RV LEAD WERE EXPLANTED AND SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400370 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R 0181| E110| E143| 1580| 0185| V-243| 1642T