BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3801320 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10935
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 5, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.UPON RECEIPT, THE HEADER WAS FOUND TO BE EXTENSIVELY DAMAGED. THE CAUSE OF THE DAMAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE-OUT FOR NORMAL ERI, THE PHYSICIAN HAD DIFFICULTY UNTIGHTENING THE SET SCREW. THE PHYSICIAN BROKE THE CONNECTOR TO RELEASE THE LEAD. A NEW SYSTEM WAS IMPLANTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279059 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3213-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR