BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTRUST

    MDR report key: 8165174 · Received December 14, 2018

    Report

    Report Number
    3002807576-2018-00358
    Event Type
    Death
    Date Received
    December 14, 2018
    Date of Event
    October 27, 2016
    Report Date
    June 17, 2019
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-2419-2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER¿S DATABASE INDICATED THE PATIENT IS DECEASED AND DIED APPROXIMATELY TEN YEARS AFTER DEVICE SYSTEM WAS IMPLANTED. THE ICD WAS RETURNED APPROXIMATELY TWO YEARS AFTER THE DATE OF DEATH. A REQUEST FOR THE CAUSE OF DEATH WAS MADE, BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006420 ENTRUST DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death 694865 LEAD