BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 1954733 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00501
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention 1581/65, (B)(4), 1056K/86, (B)(4),