BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 1896486 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-05043
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 26, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED NOISE. THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    POLY WEAR AFTER BEING IN FOR 18 YEARS WAS REPORTED. PATELLA AND POLY WERE EXCHANGED FOR NEW 3051-0910 AND 3042-0005. IMPLANTS WERE GIVEN TO THE PATIENT.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4)