BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2162483 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-08929
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RV LEAD WAS EXPLANTED AND REPLACED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED NON DETECTION AND HIGH THRESHOLDS. A CHEST X-RAY REVEALED COILING OF THE LEADS IN THE POCKET OVER TIME DUE TO TWIDDLERS SYNDROME. THE RV LEAD WAS UNABLE TO BE MANIPULATED WELL ENOUGH TO REPOSITION IN THE SUBCLAVIAN VEIN. THE RV LEAD WAS REMOVED AND REPLACED. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention