BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 2240105 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05522
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 4, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    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 PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO SYNCOPE. AN ECG SHOWED THAT PACING SPIKES WERE DELIVERED, BUT THERE WAS NO CAPTURE. THE RIGHT VENTRICULAR LEAD IMPEDANCE WAS GREATER THAN 2500 OHMS IN THE BIPOLAR CONFIGURATION. ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT'S CURRENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX S PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1646T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention