BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 1660752 · Received April 16, 2010

    Report

    Report Number
    2017865-2010-01451
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    March 22, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    PMAP910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SENSING APPROPRIATELY. BASED ON DEVICE PROGRAMMING, BASED ON DEVICE PROGRAMMING, THERAPY APPEARS TO HAVE BEEN DELIVERED APPROPRIATELY.

    Description of Event or Problem · 1

    THE PATIENT COLLAPSED AFTER SHOCKS WERE DELIVERED. PULSELESS ELECTRICAL ACTIVITY WAS DIAGNOSED. CPR AND THERAPY WERE DELIVERED. REVIEW OF SESSION RECORDS NOTED INITIAL SINUS TACH DIAGNOSIS THAT SPONTANEOUSLY BECAME VT. ATP WAS UNSUCCESSFUL AND ACCELERATED VT. HV THERAPY INDUCED VF. FIVE 36J THERAPIES DID NOT CONVERT THE RHYTHM. THE VF ULTIMATELY TERMINATED AND AV PACING WAS NOTED AT END OF ELECTROGRAM. THE PATIENT WAS DIAGNOSED WITH ANOXIC ENCEPHALOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR