BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM

    MDR report key: 1950425 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22354
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 16, 2010
    Report Date
    June 17, 2024
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040/S016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND WILL BE REPLACED IN THE NEAR FUTURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE DISPLAYED THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATORS (ERI) ONE MONTH EARLIER. THE PATIENT WITH THIS DEVICE DOES NOT REQUIRE PACING AND HAS NOT RECEIVED ANY VENTRICULAR TACHYCARDIA THERAPY. IMPEDANCE MEASUREMENTS WERE NORMAL. THERE WAS CONCERN THAT THIS DEVICE BATTERY DEPLETED MORE RAPIDLY THAN EXPECTED. A REPLACEMENT PROCEDURE IS SCHEDULED FOR THE NEAR FUTURE. THE DEVICE WILL BE RETURNED FOR ANALYSIS UPON REMOVAL. 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 1853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention