BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX LEAD

    MDR report key: 2083764 · Received May 10, 2011

    Report

    Report Number
    2017865-2011-02945
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    February 24, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    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

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FLUOROSCOPY REVEALED THE ATRIAL LEAD DISLODGED. THE LEAD WAS REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOFLEX LEAD PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1944/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention