BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3220091 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04241
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    January 6, 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

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENTRICULAR UNDERSENSING AFTER PVCS WAS OBSERVED. THE UNDERSENSING LED TO A VF DIAGNOSIS BY THE DEVICE, BUT NO THERAPY WAS DELIVERED. IT WAS DETERMINED TO BE NORMAL DEVICE BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319643 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