BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951023 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-10701
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    January 14, 2013
    Report Date
    February 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THOROUGH PRODUCT ANALYSIS WAS PERFORMED. MICROSCOPIC ANALYSIS REVEALS INSULATION DAMAGE THROUGH TO THE LUMEN 132-142 MM FROM THE TERMINAL PIN. DUE TO THE LOCATION AND TYPE OF DAMAGE, IT WAS LIKELY CAUSED BY LEAD-ON-CAN ABRASION WITH SOME TYPE OF CRUSHING MOVEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASING ARTIFACTS. THERE WAS NO INAPPROPRIATE THERAPY AS A RESULT OF THE ARTIFACTS. THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428242 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR 4555| P143| 4480| 0181