BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2905525 · Received January 9, 2013

    Report

    Report Number
    2124215-2012-13503
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    September 1, 2012
    Report Date
    November 5, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. AN EMAIL WAS SENT TO THE FIELD REPRESENTATIVE IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION RELATING TO THIS ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CLINIC HAS OPTED TO MONITOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RV LEAD CONTINUED TO EXHIBIT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS, THUS A REVISION PROCEDURE WAS SCHEDULED. PRIOR TO THE REVISION AN ELECTROPHYSIOLOGY STUDY WAS PERFORMED THROUGH THE DEVICE WHICH SHOWED A MUCH IMPROVED AND NORMAL EJECTION FRACTION IT WAS DETERMINED THE PATIENT WAS NO LONGER IN NEED OF AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). DURING THE REVISION PROCEDURE THE RV LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED. NO NEW ICD SYSTEM WAS IMPLANTED DUE TO THE PATIENT'S IMPROVED HEART CONDITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10782 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R E030| 0181| 1853