BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3337661 · Received August 23, 2013

    Report

    Report Number
    3337661
    Event Type
    Malfunction
    Date Received
    August 23, 2013
    Date of Event
    July 24, 2013
    Report Date
    August 23, 2013
    Manufacturer
    MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT ARRIVED TO ED WITH COMPLAINTS THAT HIS AICD WAS FIRING. ALARM HAD BEEN TURNED OFF 6 DAYS PRIOR, BUT IT STARTED AGAIN, AND THEN THIS AM WHILE SITTING ON THE CHAIR, HIS ICD FIRED. HE HAD KEPT HIS ACTIVITY AT A MINIMUM AND HAS NOT BEEN EXPOSED TO THE HEAT. SEEN BY THE MEDTRONIC REPRESENTATIVE IN THE ED, AND ICD WAS TURNED OFF, PACER PADS APPLIED. PT HAD NOISE ON LEAD AND IMPEDANCE TRANSIENTS, THEREFORE IT WAS BELIEVED TO BE A "LEAD OR HEADER ISSUE". PATIENT RETURNED TO OR FOR REMOVAL OF DEFECTIVE LEAD AND CHANGE OF AICD WHICH WAS CLOSE TO END OF BATTERY LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414108 SPRINT QUATTRO SECURE LEAD, CARDIAC, AICD LWS MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 6947 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR (B)(6) 2009| MEDTRONIC CONSULTA CRT-T D224TRK,#PUD208929H