BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 1896042 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04392
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    August 23, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    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 THE ANOMALY OBSERVED IN THE FIELD WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE FUNCTIONALITY WAS TESTED AND FOUND TO BE NORMAL. THE CAUSE OF THE FIELD ANOMALY WAS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO CAPTURE WAS OBSERVED. A PROBLEM IN THE CONNECTOR HEADER OF THE DEVICE WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention