BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX P

    MDR report key: 1073406 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02195
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 13, 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 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 PATIENT PRESENTED IN CLINIC WITH CHEST PAIN AND FLUTTERING. DEVICE INTERROGATION FOUND THAT VENTRICULAR LEAD IMPEDANCE HAD DECREASED FROM 793 OHMS AT IMPLANT TO 409 OHMS AND THERE WAS NO CAPTURE. REPOSITIONING WAS SCHEDULED, HOWEVER THE PATIENT EXPERIENCED INCREASED PAIN OVER THE WEEKEND AND PRESENTED TO THE EMERGENCY ROOM. A CT SCAN REVEALED PULMONARY EMBOLISM. THE LEAD WAS REPOSITIONED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX P PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1648T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention