BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3050159 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05475
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 18, 2012
    Report Date
    February 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE WAS CONTACTED; HOWEVER, WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS PACEMAKER REPORTED THAT ONE YEAR AGO HE HAD A HEART ATTACK SIX TIMES DURING THE NIGHT; WITH HEART RATES IN THE 260 PBM RANGE. THE FOLLOWING DAY, HE WENT TO THE CLINIC FOR A DEVICE INTERROGATION. THE PATIENT STATED THEY WERE TOLD BY THEIR ATTORNEY THAT THE CARDIOLOGIST BELIEVES THE PACEMAKER MALFUNCTIONED CAUSING THE HEART ATTACKS. THE PATIENT THEN HAD AN ABLATION PROCEDURE TEN DAYS LATER WHICH WENT TERRIBLY WRONG WHERE HE THEN SUFFERED A STROKE AND TEMPORARILY LOST VISION IN HIS EYES. THE PATIENT INQUIRED IF THERE WAS A WAY TO SEE IF THE DEVICE ACTUALLY MALFUNCTIONED OR IF THE EVENTS WERE RELATED TO HOW HIS DEVICE WAS PROGRAMMED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED AND ENCOURAGED THE PATIENT TO FOLLOW UP WITH THEIR CARDIOLOGIST REGARDING THE HISTORY OF THE DEVICE PROGRAMMING AND INFORMATION IN THE DEVICE MEMORY. THE PATIENT STATES HE IS STARTING TO FEEL BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149585 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening S606| 4088| 4087