BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONYX VR

    MDR report key: 3900864 · Received June 27, 2014

    Report

    Report Number
    9614453-2014-01521
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    August 1, 2011
    Report Date
    May 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE AND FOLLOW UP INFORMATION RECEIVED. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. SPECIFIC CAUSE OF DEATH HAS BEEN REQUESTED AND WAS NOT RECEIVED BY THE TIME OF THIS REPORT. REFERENCED ARTICLE: PULMONARY FLUID OVERLOAD MONITORING IN HEART FAILURE PATIENTS WITH SINGLE AND DUAL CHAMBER DEFIBRILLATORS. J. CARDIOVASC. MED. 2014;15(4):307-314. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS SYSTEM. THE PATIENT EXPERIENCED HEART FAILURE (HF). THE STATUS OF THE SYSTEM IS UNKNOWN. FURTHER FOLLOW UP DID NOT YIELD ANY ADDITIONAL INFORMATION. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THROUGH ANOTHER JOURNAL ARTICLE. THE NEW JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). FAILURE MODES IN THE ARTICLE WERE NOTED AS: ¿FALSE POSITIVE HEART FAILURE EPISODES,¿ URGENT HEART TRANSPLANTATION, AND DEATHS. IT WAS ALSO NOTED THAT THE ALERTS WERE TURNED OFF FOR SOME PATIENTS. SOME PATIENTS REACTED TO THE ALERTS BY ¿SELF-ADJUSTING¿ THEIR MEDICATIONS, AND SOME PATIENTS DID NOT HEAR THE ALERTS. ADDITIONAL INFORMATION OBTAINED THROUGH FOLLOW UP WITH THE AUTHOR INDICATED THAT THE PATIENT EXPIRED DUE TO NON-SUDDEN CARDIAC DEATH. ADDITIONAL SPECIFICS REGARDING DEATH HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376423 ONYX VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND 7290CX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 6948 RIGHT VENTRICULAR (RV) LEAD