BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 5495553 · Received March 11, 2016

    Report

    Report Number
    3004936110-2016-00008
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    February 11, 2016
    Report Date
    October 17, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT CONSISTS OF RIGHT INFORMATION.

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SENSOR IMPLANT ON (B)(6) 2016. FURTHER THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN ACUTE KIDNEY INJURY OBSERVED ON ROUTINE LABORATORY WORK DUE TO OVER DIURESIS BECAUSE OF THE ELEVATED READINGS BEING REPORTED FROM THE PATIENT ELECTRONIC SYSTEM (PEU). HOWEVER, READINGS DONE ON THE HOSPITAL ELECTRONIC UNIT (HEU) AT THE TIME OF ADMISSION, REVEALED A DISCREPANCY IN THE READINGS BETWEEN THE HEU AND PEU. THE HEU REPORTED PRESSURES 6 MM HG LOWER THAN THE PEU READINGS. THE HEU READINGS WERE MORE ACCURATE TO THE PATIENT'S CLINICAL PICTURE. AT THE TIME OF PATIENT ADMISSION, ALL DIURETICS WERE STOPPED DUE TO SUSPECTED OVER DIURESIS. AN IMPROVEMENT IN THE RENAL FUNCTION WAS OBSERVED BY THE TIME OF DISCHARGE ON (B)(6) 2016 AND THE DISCHARGE MEDICATION WERE DOSED BASED ON THE HEU READINGS. REPORTEDLY, THE PATIENT'S ISSUE IS RESOLVED BY REPLACING AND RECALIBRATING THE PEU AND HEU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151844 HF SENSOR DELIVERY SYSTEM IMPLANTABLE HF SENSOR AND DELIVERY SYSTEM MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM2000 N042502

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization