BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISENSE

    MDR report key: 1896169 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05040
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    August 9, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND MEDICAL ADHESIVE ON THE HELIX, WHICH AFFECTED THE WAY THE HELIX OPERATED.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    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