BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 3923508 · Received July 9, 2014

    Report

    Report Number
    2017865-2014-14790
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    May 8, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 FOLLOW-UP, MULTIPLE EPISODES OF NOISE CAUSING AUTO MODE SWITCH EPISODES WERE NOTED ON THE ATRIAL LEAD. THE NOISE COULD NOT BE REPRODUCED WITH PROVOCATIVE TESTS. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WOULD BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399724 OPTISENSE PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1999/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1888TC/58, BCL111656