BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA

    MDR report key: 3072526 · Received April 2, 2013

    Report

    Report Number
    3072526
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO FACILITY WITH 30 POUND WEIGHT GAIN RELATED TO SEVERE EDEMA DUE TO 6 MONTH HISTORY OF CONGESTIVE HEART FAILURE. PATIENT HAD "MIXED" CARDIOMYOPATHY WITH LEFT VENTRICULAR EJECTION FRACTION < 20% AND HAD ALSO HAD PREVIOUS PERCUTANEOUS CORONARY INTERVENTION TO THE LEFT ANTERIOR DESCENDING DURING NSTEMI APPROXIMATELY 6 MONTHS AGO. PATIENT'S HEART FAILURE RESPONDED FAVORABLY TO IV DIURETICS AND HE WAS CONSIDERED A GOOD CANDIDATE FOR PLACEMENT OF ICD FOR PRIMARY PREVENTION OF SUDDEN DEATH. AS THE PATIENT WAS UNDERGOING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE AN ACTIVE FIXATION LEAD. IT FAILED TO MAINTAIN POSITION AND THE PROVIDER REQUESTED ANOTHER WHICH ALSO FAILED. BOTH OF THESE LEADS FAILED TO MAINTAIN POSITION DESPITE MULTIPLE ATTEMPTS ALONG THE RIGHT VENTRICULAR (RV) SEPTUM AND APEX. FLUOROSCOPY DEMONSTRATED NON CONTINUOUS HELIX DEPLOYMENT FELT TO BE CONTRIBUTING TO FIXATION DIFFICULTIES. THE PROVIDER THEN REQUESTED AN ADDITIONAL LEAD FROM ANOTHER COMPANY WHICH ALSO FAILED TO POSITION CORRECTLY. EVENTUALLY A PASSIVE FIXATION LEAD WAS PLACED IN THE RV APEX WITH STABLE POSITION AND EXCELLENT PARAMETERS. THE LEAD WAS ANCHORED TO THE UNDERLYING PECTORALIS FASCIA WITH A SINGLE STITCH OF 0 SILK AND IT WAS CONNECTED TO ICD. PATIENT RETURNED LATER IN THE DAY DUE FOR EVACUATION OF HEMATOMA AND TO REPOSITION LEAD WHICH WAS THOUGHT TO BE RELATED TO PATIENT NON-COMPLIANCE WITH MOVEMENT INSTRUCTIONS.SALES REP REQUESTED RETURN OF PRODUCT AS SOON AS POSSIBLE FOR ANALYSIS. HAS OFFERED A FULL REPORT OF THEIR FINDINGS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IMPLANTATION OF ICD.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #3IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135615 DURATA LEAD, ICD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q-58 *
    135616 DURATA LEAD, ICD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122Q-58 *
    135617 SPRINT QUATRO LEAD, ICD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 6935M-62 *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR LEAD THAT WAS EVENTUALLY IMPLANTED - MEDTRONIC| MODEL #6944-65, SERIAL # (B)(4). (REQUIRED| RETURN TO EP LAB FOR REPOSITIONING)