BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2

    MDR report key: 2041681 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01968
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 16, 2011
    Report Date
    October 4, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED OVER EIGHT MONTHS LATER. EXPLANT REASON AND DATE WERE UNKNOWN. DETAILED ANALYSIS IS PENDING.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR QUALITY ASSURANCE LABORATORY THE DEVICE UNDERWENT DETAILED ANALYSIS. VISUAL OBSERVATIONS NOTED NO ANOMALIES. THE DEVICE MEMORY REVEALED THIS DEVICE HAD DECLARED THE ELECTIVE REPLACEMENT INDICATOR (ERI) PRIOR TO EXPLANT. THE ALLEGATION OF TONES WAS ALLEGED PRIOR TO ELECTIVE REPLACEMENT INDICATOR (ERI) DECLARATION. THE DEVICE WAS RECEIVED WITH THE BEEP ON MAGNET FEATURE ENABLED AND THE CHANGE TACHY MODE WITH MAGNET FEATURE DISABLED. A MAGNET APPLICATIONS AND TONE RESPONSE WAS NORMAL DURING TESTING AND COULD NOT BE REPRODUCED. IN CONCLUSION, NO ISSUES WERE REVEALED WITH TONES THROUGH ANALYSIS AND THERAPY WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE WAS NOT NOTIFIED REGARDING THIS ISSUE AND HAD NOTHING FURTHER TO PROVIDE TO THE EVENTS RESOLUTION. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS UNDERGOING AN UNDISCLOSED PROCEDURE. MAGNET APPLICATION WAS INQUIRED BY A HEALTH CARE PROVIDER. THE HEALTH CARE PROVIDER LATER REPORTED THAT THIS DEVICE WAS EMITTING TONES PRIOR TO THE MAGNET APPLICATION. THE MAGNET WAS APPLIED AND THE TONES STOPPED. HOWEVER, TONES COULD NOT BE ELICITED AGAIN WITH MAGNET APPLICATION. TECHNICAL SERVICES DISCUSSED POSSIBLE CAUSES AND ADVISED THE DEVICE BE INTERROGATED FULLY UPON COMPLETION OF THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 1860| 1790| 0125