BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PASSIVE PLUS

    MDR report key: 2905058 · Received January 9, 2013

    Report

    Report Number
    2017865-2013-00491
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    October 24, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6). NO COMPLAINT WAS RECEIVED WITH RETURN OF THE DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT A PARTIAL LEAD WAS RETURNED. AN INSULATION ABRASION WAS NOTED AT 10.2 CM TO 10.5 CM FROM THE CONNECTOR PIN. ABRASIONS ARE CONSISTENT WITH CONSTANT FRICTION WITH ANOTHER IMPLANTABLE DEVICE.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12547 PASSIVE PLUS PERMANENT PACEMAKER ELECTRODE DTB ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1246T/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1