BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRONY II

    MDR report key: 1050804 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01305
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    February 1, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DXY
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO INCREASE THE BASE RATE FROM 50 PPM TO 60 PPM, TELEMETRY WAS LOST AND COULD NOT BE RESTORED. A MAGNET RESPONSE WAS OBTAINED AT 60 PPM, INDICATING THAT PROGRAMMING WAS COMPLETED. BASED ON BATTERY VOLTAGE 2.63 V, 17 UA, 5 KOHMS, THE REMAINING LONGEVITY WAS ESTIMATED TO BE APPROXIMATELY 1.2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRONY II IMPLANTABLE PACEMAKER PULSE GENERATOR DXY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 2022L NA

    Patients

    Seq Age Sex Outcome Treatment
    1