BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSIVE PLUS

    MDR report key: 1955661 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00679
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 3, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. OTHER TEXT : NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED HIGH CAPTURE THRESHOLD OF 3.0 V AT 1.0 MS AND LOW SENSING THRESHOLD OF 0.5 MV. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSIVE PLUS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1342T/46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Required Intervention