BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK MINI+ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 74096 · Received January 16, 1997

    Report

    Report Number
    2124215-1997-00787
    Event Type
    Malfunction
    Date Received
    January 16, 1997
    Date of Event
    December 4, 1996
    Report Date
    November 22, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 EVALUATION OF THE LEAD IMPEDANCE AND R-WAVE MEASUREMENTS OF THE ICD SYSTEM. IF THE MEASUREMENTS HAVE CHANGED SIGNIFICANTLY FROM THE DATE OF IMPLANT, THE ICD SHOULD BE REPLACED. AS OF JANUARY 3, 1997, THE PATIENT HAD OPTED TO LEAVE THE ICD IMPLANTED.

    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 75 YR Other THE DEVICE 0041/213930 WAS IMPLANTED 02-DEC-1992| THE DEVICE 0041/213216 WAS IMPLANTED 02-DEC-1992