BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905240 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10798
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION REVEALED THAT THE TRILUMEN INSULATION WAS DAMAGED APPROXIMATELY 31 CENTIMETERS FROM IS-1 TERMINAL PIN. THE DAMAGE WAS MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION. THE CLINICAL OBSERVATIONS REPORTED ARE DIRECTLY RELATED TO THE DAMAGE FOUND IN LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, OVERSENSING AND INHIBITION OF PACING. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS THIS PATIENT HAD AN INTRINSIC RHYTHM. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382575 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 0185| H235| 4470| 0181| 4517