BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSIVE PLUS DX

    MDR report key: 2240375 · Received September 9, 2011

    Report

    Report Number
    2017865-2011-05447
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 19, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVN
    PMA / PMN Number
    P960030
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS WERE REVERSED IN THE HEADER OF THE PULSE GENERATOR. THE LEADS WERE REINSERTED IN THE APPROPRIATE CONNECTOR PORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 1488T/52 (B)(4)