BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 1467342 · Received September 10, 2009

    Report

    Report Number
    2017865-2009-03215
    Event Type
    Injury
    Date Received
    September 10, 2009
    Date of Event
    July 7, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS VERIFIED DEVICE RESET IN THE LABORATORY. THE DEVICE WENT INTO RESET DUE TO A DISCREPANT HYBRID COMPONENT. THE ROOT CAUSE OF THE COMPONENT FAILURE COULD NOT BE ISOLATED.

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE GAVE AN ALERT FOR BACK-UP OPERATION ONE WEEK POST IMPLANT.

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 THAT APPEARED WHILE USING THE HOMECHOICE (HC) UNIT DURING DRAIN 1 OF 3. THE CAREGIVER STATED SHE WAS ASLEEP, AND AWOKE TO THE HC ALARMING WITH A SYSTEM ERROR 2240, WHILE THE PATIENT WAS ALSO SLEEPING. THE CAREGIVER STATED THE PATIENT LINE WAS DISCONNECTED AT THE TIME OF THE ERROR, BUT THAT SHE RECONNECTED THE PATIENT. GTS ASKED THE CAREGIVER TO CLOSE THE TRANSFER SET. GTS EXPLAINED TO THE CAREGIVER THAT A LARGE AMOUNT OF AIR HAD ENTERED THE CASSETTE/LINE, AND THE SETUP HAD BEEN COMPROMISED. GTS ADVISED THE CAREGIVER THAT WHENEVER ANY LINE BECOMES DISCONNECTED, NEVER TO RECONNECT THE PATIENT OR ANY OTHER LINE AS THE SETUP BECOMES COMPROMISED. GTS HAD THE CAREGIVER CYCLE POWER, AND THE HC ALARMED WITH A SYSTEM ERROR 2367. GTS EXPLAINED THAT SYSTEM ERROR ENDS THERAPY, AND THAT THE CAREGIVER WOULD NEED TO START OVER WITH NEW SUPPLIES OR USE MANUAL SUPPLIES. GTS ADVISED THE CAREGIVER THEY WOULD NEED TO NOTIFY THE PATIENT'S NURSE, AND THE CAREGIVER ELECTED TO START THERAPY OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention