BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 1896451 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04939
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 27, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    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 PATIENT PRESENTED WITH PHRENIC NERVE INDUCED DIAPHRAGMATIC STIMULATION DUE DISLODGEMENT OF THE ATRIAL LEAD. THE PULSE GENERATOR WAS PROGRAMMED TO VVI, 60 PPM.

    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 1642T/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention