BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFP II

    MDR report key: 264224 · Received January 10, 2000

    Report

    Report Number
    2017865-2000-00156
    Event Type
    Injury
    Date Received
    January 10, 2000
    Date of Event
    October 19, 1999
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE FIELD NOTES NO MEASURED DATA FOR THE ATRIAL LEAD AND NO PACING AT 10V. VENTRICULAR LEAD IMPEDANCE WAS 1990 OHMS. IT WAS NOTED THAT THE PATIENT WAS RECOVERING AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFP II IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 283 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention