BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043160 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01815
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, THE ENTIRE LEAD WAS RECEIVED FOR ANALYSIS. VISUAL OBSERVATION REVEALED NO ABNORMALITIES AT THE TIP REGION OF THE LEAD. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. ANALYSIS COULD NOT CONFIRM ANY ABNORMALITY OF THE LEAD TIP SECTION OR HELIX THAT MAY HAVE CONTRIBUTED TO THE REPORTED CLINICAL ALLEGATION.

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD AND DEVICE REMAIN IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A REVISION PROCEDURE WAS PERFORMED. UPON OPENING THE POCKET, NO CONNECTION ISSUE WAS OBSERVED. A DECISION WAS MADE TO REPLACE THIS LEAD. DIFFICULTY WAS ENCOUNTERED IMPLANTING THE REPLACEMENT LEAD DUE TO SENSING ISSUES. FINALLY, AN ACCEPTABLE POSITION WAS FOUND. THIS LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY ONE MONTH POST IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED INCREASED THRESHOLD MEASUREMENTS THAT WERE INCONSISTENT AND INCREASING. IN ADDITION, THE INCREASED THRESHOLD MEASUREMENTS WERE ALSO OBSERVED IN THE LEFT VENTRICULAR (LV) LEAD. AS THERE WAS LOSS OF BIV PACING, LEFT VENTRICULAR LEAD DISLODGEMENT WAS SUSPECTED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED FURTHER LEAD INTERROGATION AND VERIFICATION OF THE DF-4 LEAD CONNECTION. NO OUT OF RANGE IMPEDANCE MEASUREMENTS HAD BEEN OBSERVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED. FURTHER REVIEW OF THIS RV LEAD AND DEVICE REVEALED THE DEVICE HAS MIGRATED DOWNWARDS FROM THE IMPLANTED POSITION. A REVIEW OF THE DAILY MEASUREMENTS REVEALED THE SHOCK IMPEDANCE HAS DECREASED SLIGHTLY, HOWEVER REMAINS WITHIN NORMAL LABELING GUIDELINES. THIS LEAD IMPEDANCE HAS DECREASED SIX HUNDRED OHMS SINCE THE LAST MEASUREMENT AND THE RV THRESHOLDS HAVE INCREASED. IT WAS THOUGHT THE DEVICE HAS MIGRATED AND THE LV LEAD IS DISLODGED. A SYSTEM REVISION IS INTENDED AND FURTHER RV LEAD INTEGRITY IS RECOMMENDED. IT WAS THOUGHT THERE MAY BE A CONNECTION ISSUE HOWEVER AS THE RV LEAD IMPEDANCE MEASUREMENTS ARE WITHIN NORMAL LABELING RANGE, THIS MAY SUGGEST A LEAD ISSUE. IT WAS FURTHER THOUGHT THAT AS THE DEVICE HAS MIGRATED, THE RV LEAD MAY HAVE ALSO STRETCHED AND MAY BE CONTRIBUTING TO THE REPORTED CLINICAL OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147772 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1