BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 1073347 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02141
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    May 12, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED 2196 OHMS IMPEDANCE. THE PULSE GENERATOR WAS REPROGRAMMED TO 3.5 V, 0.4 MS. DUE TO PATIENT'S AGE AND OVERALL CONDITION THE LEAD WOULD NOT BE REPLACED AS IT WAS STILL FUNCTIONAL. THE PATIENT WAS NOT PACEMAKER DEPENDENT.

    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/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1