BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 1896435 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05205
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 8, 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
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED FINAL ANALYSIS FOUND THE PROXIMAL AND DISTAL INSULATIONS ABRADED AND ALL FIVE WIRES OF THE PROXIMAL COIL FRACTURED AT 22.5CM FROM THE CONNECTOR PIN DUE TO CLAVICULAR CRUSH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. TWIDDLER'S SYNDROME WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1999/40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention