BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040658 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00470
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 3, 2013
    Report Date
    March 28, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED IN TWO SEGMENTS, SEVERED 13 CENTIMETERS (CM) FROM THE TERMINAL PIN. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. THE RS- PORTION OF THE DISTAL SEGMENT WAS NOT TESTED DUE TO THE EXTRACTING STYLET BEING RETURNED IN THE LEAD. AN X-RAY WAS PERFORMED ON THIS SECTION WHICH REVEALED ALL CONDUCTORS WERE INTACT. MICROSCOPIC INSPECTIONS OF THE ELECTRODE TIP FOUND CALCIFICATION ON THE LEAD. CALCIFICATION ON THE LEAD TIP COULD AFFECT THE IMPEDANCE MEASUREMENTS.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS NOT BROUGHT INTO CLINIC FOR FURTHER EVALUATION AND THE SYSTEM WILL CONTINUE TO BE MONITORED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT WAS SEEN IN CLINIC. SHOCK IMPEDANCE MEASUREMENTS WERE BETWEEN 115 AND 126 OHMS. THE DEVICE AND LEAD WILL CONTINUE TO BE MONITORED VIA REMOTE MONITORING. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THESE PRODUCTS REMAIN IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS CONTINUE TO BE OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING AN INVASIVE PROCEDURE WAS PERFORMED. THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD WERE EXPLANTED AND REPLACED WITH A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143846 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R E102| 0181