BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2060001 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-05786
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 29, 2011
    Report Date
    May 26, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    SUBSEQUENT ALERTS CONTINUED, THUS THE PHYSICIAN ELECTED TO SURGICALLY INTERVENE. AN ADEQUATE CONNECTION WAS CONFIRMED PRIOR DISCONNECTING THE LEAD FROM THE DEVICE HEADER. THE RIGHT VENTRICULAR SHOCK AND PACE/SENSE TERMINAL CONNECTION WAS REMOVED AND CLEANED, THEN CONNECTED TO THE PSA FOR PARAMETER EVALUATION. VALUES OBTAINED WERE SIMILAR TO THE ONES CONFIRMED PRIOR TO THE INTERVENTION. NO FURTHER SYSTEM CHANGES WERE PERFORMED AND THE LEAD AND DEVICE CONNECTION REESTABLISHED. THE FINAL IMPEDANCE READS WERE APPROXIMATELY 500 OHMS LESS THEN PREVIOUS VALUES, WITH ACCEPTABLE THRESHOLDS AND AMPLITUDES OBSERVED. PATIENT CONDITION REMAINED FAVORABLE AND NO OTHER INTERVENTION PERFORMED.

    Description of Event or Problem · 1

    DURING THE NEXT FOLLOW-UP VISIT, HIGH VALUES CONTINUED TO BE EXHIBITED. AN X-RAY WAS PERFORMED, CONFIRMING APPROPRIATE LEAD POSITIONING WITHIN THE HEADER PORT. POCKET MANEUVERS SHOWED NO SYSTEM NOISE. THEY PHYSICIAN ELECTED TO NOT SURGICALLY INTERVENE AT THIS TIME AND WILL CONTINUE TO FOLLOW PROGRESS WITH LATITUDE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE FIRST REGULARLY SCHEDULED FOLLOW-UP POST NEW DEVICE IMPLANT WITH THIS CHRONIC RIGHT VENTRICULAR LEAD, HIGH OUT OF RANGE PACE/SENSE IMPEDANCE VALUES WERE EXHIBITED. DAILY MEASUREMENTS SENT TO BOSTON SCIENTIFIC INTERNAL TECHNICAL SERVICES FOR ROOT CAUSE CONSIDERATION. NO ADVERSE PATIENT EFFECTS REPORTED AND THE PATIENT WAS DISMISSED UNTIL THE NEXT REGULARLY SCHEDULED FOLLOW-UP IN THREE MONTHS. TECHNICAL SERVICES REVIEWED THE INFORMATION, RESPONDING TO THE FIELD REPRESENTATIVE THAT IT WAS LIKELY A CONNECTION ISSUE AND AN X-RAY WOULD BE BENEFICIAL.

    Description of Event or Problem · 1

    SUBSEQUENTLY A FOLLOW-UP VISIT WAS PERFORMED AND THE RV PACE/SENSE MEASUREMENTS EVALUATED. IMPEDANCE VALUES WERE STABLE AT 1592 OHMS, WITH ALL OTHER LEAD MEASUREMENTS SIMILARLY STABLE FROM THE PREVIOUS FOLLOW-UP. WITH NO ADVERSE PATIENT EFFECTS REPORTED AND NO FURTHER INFORMATION TO INDICATE A PRODUCT PERFORMANCE ISSUE, THE PATIENT WAS RELEASED FOR NORMAL FOLLOW-UPS. THE PHYSICIAN MADE NO ALLEGATIONS AGAINST THE LEAD OR DEVICE AND INDICATED THE PATIENT WOULD BE FOLLOWED VIA THE LATITUDE REMOTE MONITORING SYSTEM. AT THIS TIME, NO SYSTEM CHANGES WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1