BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 1853940 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-18073
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. THERE WERE NO BREACHES IN THE DEVICE CASE AND THE HEADER WAS SECURE. THERE WERE PIECES OF WHITE RESIDUE ON THE DEVICE CASE AND HEADER. THIS RESIDUE WAS TESTED AND WAS FOUND TO BE PRIMARILY COMPOSED OF CALCIUM, PHOSPHOROUS AND OXYGEN INDICATING THAT THE WHITE RESIDUE WAS MOST LIKELY THE RESULT OF SOME DEPOSITS FROM THE BODY WHILE IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) A FEW MONTHS AGO. THE DEVICE CHANGE OUT PROCEDURE WAS DELAYED DUE TO THE PATIENT'S NEED FOR ABDOMINAL SURGERY (DIVERTICULITIS). DUE TO THE LONG CHARGE TIME MEASUREMENT, THE PATIENT HAD BEEN WEARING A LIFEVEST. THE PATIENT HAS HEALED AND THE CHANGE OUT PROCEDURE WAS SCHEDULED. IT WAS NOTED THAT THERE WERE A FEW EPISODES OF NOISE ON THE RATE\SENSE CHANNEL OF THE COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD. DURING THE CHANGE OUT PROCEDURE, THEY NOTED A WHITE MILKY SUBSTANCE ON THE DEVICE. TECHNICAL SERVICES (TS) DISCUSSED THAT THE DEVICE IS HERMETICALLY SEALED. IT WAS NOTED THAT THIS SUBSTANCE WAS UNFAMILIAR TO SEVERAL PHYSICIAN'S. THE PHYSICIAN DOES NOT BELIEVE IT IS AN INFECTION, POSSIBLY ALLERGIES OR BARIUM AS A RESULT OF THE ABDOMINAL SURGERY FOR DIVERTICULITIS. THE PHYSICIAN INDICATED THAT A CULTURE WOULD BE PERFORMED AND THE DEVICE WOULD BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION INDICATED THAT THE FIELD REPRESENTATIVE WAS NOT AWARE OF THE CULTURE RESULTS. AT THIS TIME, THE PATIENT WILL CONTINUE TO WEAR THE LIFEVEST UNTIL A NEW SYSTEM COULD BE IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1857

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention 5866-22| 1746| MISMATCH| 5024M| 1857| 6921M