BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSIVE PLUS

    MDR report key: 2013988 · Received March 10, 2011

    Report

    Report Number
    2017865-2011-01338
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 2, 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
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND EROSION. THE LEAD WAS REMOVED. DURING EXTRACTION, THE LEAD TIP DETACHED FROM THE LEAD AND WAS NOT RECOVERED.

    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 84 YR Required Intervention (B)(4)