BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 1955925 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00742
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    November 30, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 LOSS OF CAPTURE ON SURFACE ELECTROGRAMS AT A ROUTINE FOLLOW-UP. THE PATIENT WAS ASYMPTOMATIC. ISOMETRIC AND POSITIONAL TESTING COULD NOT REPRODUCE ANY ANOMALIES. PACING OUTPUTS WERE INCREASED TO 3.5 V AT 0.5 MS AND THE PATIENT WOULD BE MONITORED.

    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 93 YR (B)(4)