BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 2240119 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05606
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 12, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS REVEALED THAT THE LEAD WAS CUT AND RETURNED IN TWO PIECES. THE INSULATION WAS EXTERNALLY ABRADED AT 5.6 - 6.7 CM FROM THE CONNECTOR PIN. THE LOCATION OF THE ABRASION IS CONSISTENT WITH THAT OF FRICTION TO ANOTHER IMPLANTED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION. THE PLACEMENT OF THE ATRIAL LEAD TIP WAS FOUND TO BE POOR. THE LEAD WAS REMOVED AND REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention 1888TC/58 (B)(4)