BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 2983909 · Received February 28, 2013

    Report

    Report Number
    2017865-2013-01434
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 16, 2013
    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 LEAD EXHIBITED IMPEDANCE LESS THAN 200 OHMS AND THE INSULATION WAS BROKEN. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88953 ISOFLEX S PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1646T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention