BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK MINI+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 94025 · Received March 6, 1997

    Report

    Report Number
    2124215-1997-00859
    Event Type
    Injury
    Date Received
    March 6, 1997
    Date of Event
    December 5, 1996
    Report Date
    December 4, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION DURING REVIEW OF MANUFACTURING PROCESSES, CPI DETERMINED THAT THIS VENTAK MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) MAY NOT HAVE THE REQUIRED MEDICAL ADHESIVE IN THE ICD'S LEAD CONNECTOR BLOCK. BECAUSE OF THIS SITUATION, IT MAY BE POSSIBLE FOR FLUIDS TO ENTER THE CONNECTOR BLOCK AND AFFECT THE ICD'S ABILITY TO RECOGNIZE AND TREAT ARRHYTHMIAS. CPI NOTIFIED THE PHYSICIAN ON NOVEMBER 22, 1996, AND RECOMMENDED IMMEDIATE REPLACEMENT OF THE ICD. THE ICD WAS REPLACED; IT WAS OBSERVED DURING REPLACEMENT OF THE ICD THAT THERE WAS BLOOD IN THE HEADER OF THE ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK MINI+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS 1746 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention THE DEVICE 0074/001711 WAS IMPLANTED 12-OCT-1993| THE DEVICE 1746/602055 WAS IMPLANTED 04-DEC-1996