BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 3040742 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02207
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 7, 2013
    Report Date
    February 26, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED THE FOLLOWING MONTH. THE DEVICE HAS NOT BEEN RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. THE MONITORING VOLTAGE WENT FROM 2.83V TO 2.66V IN FOUR MONTHS. THE PATIENT HAD INFORMED THE CALLER THAT HER PAST DEVICES HAD LASTED LONGER THAN THIS ONE. THE CALLER STATED THAT WHEN THE DEVICE IS EXPLANTED IT WILL BE RETURNED FOR EVALUATION TO CONFIRM IF THE DEVICE LONGEVITY WAS APPROPRIATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144060 VENTAK PRIZM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1857

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization 1789| MISMATCH| 1857| 0064