BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTISENSE

    MDR report key: 2013919 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01631
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 17, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960013
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 ONE DAY POST IMPLANT, THE ATRIAL LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLD FROM 0.5 V AT 0.5 MS TO 1.75 V AT 0.5 MS, A DROP IN P-WAVE AMPLITUDE FROM 4 MV TO 0.3 MV AND A DROP IN IMPEDANCE FROM 490 OHMS TO 360 OHMS DUE TO DISLODGEMENT. THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE PATIENT REMAINED ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTISENSE PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1999/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention