BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1041749 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34907
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 16, 2016
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SIX MONTHS LATER, DURING THE PATIENT'S NEXT SCHEDULED LATITUDE DEVICE INTERROGATION, ANOTHER RED ALERT WAS GENERATED FOR SHOCK IMPEDANCE MEASUREMENTS THAT WERE ABOVE THE LATITUDE PROGRAMMED ALERT LEVEL, BUT WITHIN SPECIFICATION. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED. -- THE DEVICE WAS SUBSEQUENTLY EXPLANTED FOLLOWING THE DEATH OF THIS PATIENT FOR UNSPECIFIED REASONS TWO YEARS AFTER THE INITIAL OBSERVATIONS WERE REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HAD NO TELEMETRY, A MEMORY DOWNLOAD COULD NOT BE PERFORMED AND THE DEVICE DATA WAS INSUFFICIENT TO OBTAIN BATTERY STATUS. THE DEVICE WENT INTO A NO TELEMETRY STATE DUE TO THE BATTERY DEPLETING OVER THE SIX YEARS FROM EXPLANT UNTIL THE DEVICE WAS RETURNED. THE REPORTED CLINICAL OBSERVATION OF A HIGH AND OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE ASSOCIATED WITH A LATITUDE RED ALERT FOR A PRE-EXISTING HIGH SHOCK IMPEDANCE MEASUREMENT WHEN THE PATIENT'S DEVICE WAS FIRST INTERROGATED BY THE LATITUDE COMMUNICATOR. THE EXISTING DATA IN LATITUDE FOR THE PAST YEAR SHOWED WEEKLY AVERAGE IMPEDANCE MEASUREMENTS FROM 70-80 OHMS, AND THE LATITUDE ALERT THRESHOLD WAS AT THE PRE-SET LEVEL OF 80 OHMS. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS, AND THE DEVICE AND LEAD REMAIN IMPLANTED AND IN SERVICE. --

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CLONMEL IRELAND 1860 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 6481 054057 WAS USED DURING THE EVENT.