BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D, DF4 CONNECTOR

    MDR report key: 2984586 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00554
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    September 11, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED DUE TO POCKET INFECTION. HEMATOMA WITH WOUND DEHISCENSE AND ONSET OF FEVER WERE OBSERVED. THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85951 PROMOTE PLUS CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3211-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)