BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 3854581 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11600
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT MEASUREMENTS SHOWED AN INCREASE IN PACING IMPEDANCE AND CAPTURE THRESHOLD. THE SET SCREW ON THE DEVICE WAS FOUND TO BE LOOSE. THE POCKET WAS OPENED AND THE SET SCREW WAS TIGHTENED DOWN. NORMAL MEASUREMENTS WERE OBSERVED. THE PATIENT CONDITION WAS STABLE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332021 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention