BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1952581 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23543
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 13, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. A BOSTON SCIENTIFIC TECHNICAL SERVICE CONSULTANT REVIEWED THE REAL TIME ECG/EGM (IN REGARDS TO THE VP-TR MARKERS NOTED) WITH ENGINEERING AND IT WAS DISCUSSED THAT FROM THE ECG/EGM, ONLY VP-TR WERE MARKED UNTIL THE END OF THE RUN. THE ECG/EGM PRINTOUT WAS PRINTED AT THE SAME TIME SHOCKING IMPEDANCE MEASUREMENTS WERE DONE BY HOLDING THE START BUTTON. ENGINEERS CONFIRMED THAT THE MARKERS LINKED TO THE SHOCKING IMPEDANCE TESTS. ENGINEERS SUCCEEDED IN REPRODUCING A SIMILAR SCENARIO. SHOCKING IMPEDANCE MEASUREMENTS ARE SYNCHRONOUSLY TRIGGERED WITH A SENSED-R-WAVE. A TEST PULSE IS DELIVERED 20MS AFTER THE SENSED R-WAVE WHILE DOING A MANUAL LEAD IMPEDANCE TEST. THIS IS CONSISTENT WITH WHAT WAS OBSERVED. REGARDING THE FAST RHYTHM, IT IS LIKELY THAT THE PATIENT WENT INTO A RUN OF VENTRICULAR TACHYCARDIA DURING THE TEST. AS THE "START" BUTTON WAS HELD, VP-TR MARKERS WERE SHOWN. NO RHYTHM ACCELERATION IS EXPECTED DURING THIS TEST. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED AND AN AMENDED REPORT SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS NOT RETURNED TO BOSTON SCIENTIFIC. 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

    APPROXIMATELY ONE YEAR LATER, ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED WITHOUT FURTHER ALLEGATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE FOLLOW UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR REVEALED A DAILY SHOCK IMPEDANCE VALUE BELOW 20 OHMS ON (B)(6), 2010. (LEAD MODEL AND SERIAL NUMBER UNKNOWN) NO WARNING OR POP-UP WINDOW WAS NOTED UPON INTERROGATION. THE MEASUREMENT WAS ONLY VISIBLE WHEN CLICKING ON THE EVENT IN THE CLINICAL SUMMARY WINDOW. THE SHOCK IMPEDANCE TREND HAD BEEN RATHER STABLE FROM 55 OHMS AT IMPLANT TO 46 OHMS ON (B)(6), 2010. NO NOISE WAS OBSERVED ON THE EGM'S. IN ADDITION, VP-TR MARKERS WERE NOTED DURING THE REAL TIME ECG/EGM. A BOSTON SCIENTIFIC TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND DISCUSSED THAT WITH VITALITY HE, AN OUT OF RANGE DAILY SHOCK LEAD INTEGRITY TEST WILL CAUSE THE DEVICE TO BEEP (16 TIMES EVERY 6 HOURS). OUT OF RANGE VALUES FOR SHOCK IMPEDANCE ARE LESS THAN 20 OHMS AND GREATER THAN 125 OHMS. THE NORMAL RANGE FOR SHOCK IMPEDANCE IS 20-80 OHMS. AUTOMATIC DAILY SHOCK MEASUREMENTS PROVIDE A MESSAGE ON THE SYSTEM SUMMARY SCREEN IF DAILY MEASUREMENT SHOCK IMPEDANCES FALL OUTSIDE OF THE RANGE. THE CLINICAL OBSERVATIONS NOTED APPEAR TO BE THE NORMAL BEHAVIOUR. DAILY VARIATIONS OF APPROXIMATIVELY 5 OHMS ARE TO BE EXPECTED. ANY ABRUPT OR LARGE IMPEDANCE FLUCTUATIONS OR OUT-OF-RANGE CONDITIONS IN DAILY READINGS MAY BE INVESTIGATED. POSSIBLE REASONS THAT MAY CAUSE LOW SHOCKING IMPEDANCE: THE SHOCKING ELECTRODES (OR CONDUCTOR IN CASE OF LEAD ISSUE) MAY BE VERY CLOSE TO EACH OTHER OR ACTUALLY TOUCHING. AN OPEN LEAD INSULATION DEFECT. AN EMI INTERACTION DURING THE DAILY SHOCK LEAD IMPEDANCE MEASUREMENT. A LEAD INSULATION DEFECT MAY NOT BE PERMANENTLY OPENED. DEPENDING ON LEAD POSITION AND MOVEMENT, AN INSULATION DEFECT MAY RANDOMLY OPEN AND IN CONJUNCTION WITH A SHOCK LEAD IMPEDANCE TEST, PRODUCE A LOW IMPEDANCE MEASUREMENT. DIAGNOSTIC AND SYSTEM EVALUATION OPTIONS MIGHT BE CONSIDERED TO FURTHER EVALUATE THE LEAD INTEGRITY OR ISOLATE AN UNDERLYING POTENTIAL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R