BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISENSE

    MDR report key: 4231322 · Received November 6, 2014

    Report

    Report Number
    2017865-2014-18113
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 18, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 DURING DEVICE UPGRADE, IT WAS NOTED THAT THE ATRIAL LEAD EXHIBITED AN INSULATION ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715533 OPTISENSE PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1999/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)