BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTAK PRX III IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 69196 · Received January 9, 1997

    Report

    Report Number
    2124215-1997-00357
    Event Type
    Death
    Date Received
    January 9, 1997
    Date of Event
    September 26, 1996
    Report Date
    September 26, 1996
    Manufacturer
    CARDIAC PACEMAKERS
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS PREVIOUSLY SUBMITTED ON EDI #2124215000199700357. BASED ON NEW INFO RECEIVED WITH THE MEDWATCH FORM(FDA MEMO, DATED OCTOBER 10, 1997), THE DEVICE WAS ACCIDENTLY PROGRAMMED TO THE "MONITOR ONLY" MODE DURING A ROUTINE FOLLOW-UP BY A HEALTH CARE PROFESSIONAL.

    Description of Event or Problem · 1

    EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT A PATIENT WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPIRED ON 9/23/96. ON 9/24/96, THE ICD WAS INTERROGATED AND FOUND TO BE IN THE 'MONITOR ONLY' MODE, NOT IN THE 'MONITOR + THERAPY' MODE. IN THE 'MONITOR ONLY' MODE THE ICD WILL MONITOR A PATIENT'S VENTRICULAR ARRHYTHMIA, BUT DELIVER NO THERAPY. THE PATIENT'S HUSBAND DID NOT WANT AN AUTOPSY PERFORMED OR HAVE THE ICD EXPLANTED FOR ANALYSIS. THE CAUSE OF DEATH HAS NOT BEEN IDENTIFIED, BUT BECAUSE OF THE PATIENT'S MEDICAL HISTORY (AND EPISODE DATA STORED IN THE DEVICE MEMORY) IT'S SUSPECTED TO BE RELATED TO A VENTRICULAR ARRHYTHMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRX III IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Implant IMPLANTABLE CARDIOVERTER DEFIBRILLATOR 6.1 CONNECTOR LWS CARDIAC PACEMAKERS 1725 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death