BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    META DDDR

    MDR report key: 688216 · Received March 10, 2006

    Report

    Report Number
    2017865-2006-00478
    Event Type
    Malfunction
    Date Received
    March 10, 2006
    Date of Event
    January 1, 2006
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD DOES NOT ADDRESS THE PATIENT'S CLINICAL STATUS BUT NOTES THAT THE THRESHOLD TEST COULD NOT BE RUN. A MESSAGE WAS DISPLAYED THAT TELEMETRY WAS LOST AND THE TEST WOULD BE TERMINATED. ALTHOUGH MULTI- PLE ATTEMPTS TO OBTAIN MEASURED DATA WERE UNSUCCESSFUL, ONE ATTEMPT GAVE A MAGNET RATE AS 95 PPM WITH <300 OHMS ATRIAL IMPEDANCE AND >3000 OHMS VENTRICULAR IMPEDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 META DDDR IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1256 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR