BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3101059 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01861
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 19, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT HIGH HV LEAD IMPEDANCE MEASUREMENT WAS OBSERVED. DEVICE REPLACEMENT IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203509 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3213-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1