BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040827 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01939
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. INSPECTION OF THE LEAD BODY AND ELECTRODE TIP FOUND NO ANOMALIES. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE LEAD'S ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD APPEARED TO HAVE DISLODGED DURING AN AV NODE ABLATION. THE EP CATHETERS MAY HAVE CAUSED THE LEAD TO MOVE. AFTER THE AV NODE WAS FULLY ABLATED, THE PATIENT EXPERIENCED PACING PAUSES OF GREATER THAN TWO SECONDS. FINAL RV PACING THRESHOLD MEASUREMENTS WERE [email protected]. DUE TO THE HIGH THRESHOLDS AND INTERMITTENT LOSS OF CAPTURE, THIS LEAD WAS EXPLANTED AND REPLACED. THE NEW LEAD WAS CONNECTED TO THE EXISTING DEVICE, WITH NORMAL THRESHOLD MEASUREMENTS OBSERVED. THE PATIENT WAS DOING WELL AND NO ADVERSE EVENTS OCCURRED DURING THE LEAD REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143441 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening| R 0185| 0175| E161