BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 1223823 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03457
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    August 20, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    PMAP960013
    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 THE PATIENT PRESENTED TO EMERGENCY ROOM COMPLAINING OF DIAPHRAGMATIC STIMULATION. INTERROGATION REVEALED THAT THE ATRIAL LEAD HAD DISLODGED. THE LEAD WAS SUCCESSFULLY REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1699TC/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention