BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 2014129 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01628
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 16, 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
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED LOSS OF SENSING. WHEN THE POCKET WAS OPENED, THE LEAD WAS FOUND TO BE TWISTED AND DISLODGED DUE TO TWIDDLER'S SYNDROME. THE PATIENT WAS SYMPTOMATIC. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1999/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention (B)(4)