BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSIVE PLUS DX

    MDR report key: 1896663 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04882
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    September 24, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    P960030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED OTHER TEXT : DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED GREATER THAN 1200 OHMS IMPEDANCE. THE LEAD WAS EXPLANTED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSIVE PLUS DX PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1346T/58

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention