BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPO

    MDR report key: 735220 · Received May 9, 2006

    Report

    Report Number
    2017865-2006-00657
    Event Type
    Injury
    Date Received
    May 9, 2006
    Date of Event
    February 28, 2006
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED E3 - 000 - SALES REPRESENTATIVE

    Description of Event or Problem · 1

    THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH. THE DEVICE WAS PACING AT THE MAXIMUM SENSOR RATE (MSR) OF 130 PPM. THE DEVICE WAS PROGRAMMED BACK TO 70 PPM IN VVI MODE. THE PATIENT USED A HOME BLOOD PRESSURE MONITOR BUT REPORTED THAT HIS RATE DID NOT INCREASE UNTIL HE WAS ADMITTED TO THE EMERGENCY ROOM. REPEATING THE TEST WITH THE SAME EQUIPMENT DID NOT RESULT IN MSR PACING. THE DEVICE REPORTEDLY PACED AT MSR FOLLOWING THE PATIENT'S DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPO IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1102 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention