BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 3901077 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12578
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR POCKET REVISION DUE TO UNEXPLAINED HEMATOMA. POSSIBLE POCKET INFECTION WAS NOTED. THE SYSTEM WAS EXPLANTED. THE PATIENT CONDITION IS GREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381284 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention (B)(4)