BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISENSE

    MDR report key: 4143294 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05755
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 21, 2011
    Manufacturer
    ST JUDE MED, INC. CRMD
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. A COMPLETE INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE PACKAGING WAS NOT RETURNED. THE LEAD EXHIBITED NORMAL CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SEAL OF THE INSIDE STERILIZED PACKAGING OF A LEAD WAS BROKEN WHEN IT WAS BEING PREPARED FOR IMPLANT. ANOTHER LEAD WAS INSTEAD USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28659 OPTISENSE PERMANENT PACEMAKER ELECTRODE NVN ST JUDE MED, INC. CRMD 1699TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1