BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 1050910 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01314
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 20, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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 THE PULSE GENERATOR WAS PROGRAMMED TO VVI WITH AUTOCAPTURE TURNED ON AT 2.6 V, 0.5 MS AND SHOWING INTERMITTENT VENTRICULAR CAPTURE. DUE TO INSUFFICENT RHYTHM, THE EVOKED RESPONSE TEST COULD NOT BE RERUN AND COMPLETED. THE RATE WAS INCREASED TO 125 PPM FOR THE TEST, CAPTURE THRESHOLDS WERE THEN 1.5 V, 0.5 MS. THE PULSE GENERATOR WAS PROGRAMMED AUTOCAPTURE OFF WITH THE DEVICE SET TO HIGH OUTPUT SETTINGS. THE LEAD WAS SUBSEQUENTLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX S PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1646T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention