BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2268837 · Received September 8, 2011

    Report

    Report Number
    2268837
    Event Type
    Malfunction
    Date Received
    September 8, 2011
    Date of Event
    July 5, 2011
    Report Date
    September 8, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ELDERLY PATIENT HAD A HISTORY OF CARDIAC CACHEXIA, SCLERODERMA AND SUDDEN CARDIAC DEATH SYNDROME. HER DEVICE HAD BEEN RELOCATED TO A SUBPECTORAL LOCATION AT THE TIME OF GENERATOR CHANGE SIX MONTHS AGO (THE ORIGINAL LEAD WAS INTACT AND FUNCTIONING). FIVE DAYS PRIOR TO THIS ADMISSION SHE PRESENTED WITH THE NOISE ON HER PACE SENSE COMPONENT TO THE EXTENT THAT THE DEVICE WAS TURNED OFF. THE DEVICE HAD MIGRATED CRANIALLY AND LATERALLY, IT WAS CAUSING PAIN IN THE AXILLA. THE PATIENT WAS ADMITTED FOR LEAD MANAGEMENT AND POSSIBLE POCKET REVISION. THE PATIENT'S OPERATIVE PROCEDURE INVOLVED REMOVAL OF THE OLD SYSTEM IN ITS ENTIRETY AND REPLACEMENT WITH NEWER TECHNOLOGY INVOLVING SHORTER THINNER LEAD AND A SMALLER DEVICE, LOCATING IT TO A MORE MEDIAL AND CAUDAL LOCATION STILL WITHIN THE SUBPECTORAL SPACE. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LEAD, PACEMAKER DTB ST. JUDE MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR