BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 4884744 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-07512
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 5, 2014
    Report Date
    May 28, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THAT THE DEVICE HEADER WAS LOOSE BUT NOT SEPARATED FROM THE DEVICE. X-RAY EXAMINATION CONFIRMED THAT THE DEVICE RV TIP, A TIP, A RING, DF+ AND DF- FEED-THRU WIRES WERE FRACTURED. AN ENGINEERING-LEVEL LONGEVITY PREDICTION CALCULATION WAS COMPLETED TO ASSESS THE RATE OF BATTERY DEPLETION. GIVEN THE PROGRAMMED PARAMETERS AND OTHER DATA STORED WITHIN THE MEMORY OF THE DEVICE, THE RESULTS OF THIS CALCULATION INDICATED THAT THE ACTUAL RATE OF BATTERY DEPLETION FELL WITHIN AN ACCEPTABLE RANGE. THERAPY TESTING ON THE DEVICE WAS UNABLE TO BE PERFORMED AS A RESULT OF THE FRACTURED FEED-THRU WIRES, HOWEVER EXAMINATION OF THE DEVICE MEMORY SHOWED THAT ALL DEVICE LEAD IMPEDANCE MEASUREMENTS WERE GOOD AT THE TIME OF EXPLANT AND THAT THERAPY WAS AVAILABLE AT TIME OF EXPLANT. EVIDENCE INDICATES THAT THE LOOSE HEADER WAS CAUSED BY EXTERNAL STRESS DURING THE EXPLANT PROCEDURE. MANUFACTURING ENHANCEMENTS HAVE BEEN IMPLEMENTED TO MAKE THE HEADER BOND MORE ROBUST.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION WITH RIGHT VENTRICULAR RESPONSE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED PROGRAMMING OPTIONS. THE FOLLOWING DAY THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF HEARING TONES FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS NOTED THAT THERE WERE NO ISSUES WITH THE DEVICE FOUND UPON INTERROGATION AND THE PATIENT HAD NOT RECEIVED A SHOCK ON THAT DAY. THE PHYSICIAN OPTED TO CONTINUE TO MONITOR THE PATIENT. TWO MONTHS LATER THE PHYSICIAN PERFORMED NON-INVASIVE PROGRAMMED STIMULATION (NIPS) TESTING IN ORDER TO DETERMINE THE CORRECT PROGRAMMING FOR THE PATIENT. THE SYSTEM REMAINED IMPLANTED WITH NO FURTHER ISSUES. THE ICD WAS EXPLANTED EIGHT MONTHS LATER FOR ELECTIVE REPLACEMENT INDICATOR (ERI). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428689 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR T180| 0158| 4087