BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 1896582 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04943
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 9, 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
    WV
    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 RIGHT VENTRICULAR LEAD DISLODGED. THE LEAD WAS REPLACED.

    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 67 YR Required Intervention