BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISENSE

    MDR report key: 4121494 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07758
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    May 30, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, 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. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF UNSTABLE LEAD IMPEDANCE WAS CONFIRMED IN THE LABORATORY. AN INTERMITTENT SHORT CIRCUIT IN THE LEAD DUE TO INNER INSULATION DAMAGE NEAR THE CONNECTOR PORTION WAS NOTED. THE CAUSE OF THE INNER INSULATION DAMAGE WAS OVERTORQUE OF THE INNER COIL IN THE FIELD DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE ATRIAL LEAD EXHIBITED LOW LEAD IMPEDANCE. THE LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32413 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC., CRMD 1999/52

    Patients

    Seq Age Sex Outcome Treatment
    1