BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 5663806 · Received May 18, 2016

    Report

    Report Number
    3004936110-2016-00026
    Event Type
    Injury
    Date Received
    May 18, 2016
    Date of Event
    March 9, 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
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (CORRECTED DATA): (INITIAL REPORTER): INFORMATION IN INITIAL REPORTER WAS INADVERTENTLY REPORTED INCORRECT IN THE INITIAL REPORT. THIS REPORT CONSISTS OF CORRECT INFORMATION. (MANUFACTURER CONTACT): INFORMATION IN MANUFACTURER CONTACT WAS INADVERTENTLY OMITTED IN THE INITIAL REPORT. THIS REPORT CONSISTS OF MISSING INFORMATION. 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 WAS UNABLE TO OBTAIN PRESSURE READINGS USING THE PATIENT ELECTRONIC UNIT (PEU). A REPLACEMENT PEU WAS UNABLE TO RESOLVE THE ISSUE. CHEST X-RAYS REVEALED THE HF SENSOR HAD MIGRATED FROM THE LEFT SIDE TO THE RIGHT SIDE. A SJM REPRESENTATIVE CONDUCTED A HOME VISIT TO TRY TROUBLESHOOTING TO NO AVAIL AS NO READING WAS OBTAINED. THE PATIENT PRESENTED AT THE CLINIC WITH THE PEU FOR TROUBLESHOOTING. AFTER TROUBLESHOOTING GOOD WAVEFORM AND PRESSURE READINGS WERE OBTAINED WITH THE HOSPITAL ELECTRONIC UNIT (HEU) AND A FEW READINGS WERE OBTAINED ON PATIENT'S PEU. HOWEVER, IT WAS DETERMINED IT WILL NOT BE POSSIBLE FOR THE PATIENT TO DUPLICATE THE TROUBLESHOOTING TECHNIQUE (POSITIONING REQUIRED TO KEEP A STEADY CONNECTION TO COMPLETE THE READING) AT HOME IN ORDER TO TRANSMIT DAILY READINGS. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317760 HF SENSOR DELIVERY SYSTEM IMPLANTABLE HF SENSOR AND DELIVERY SYSTEM MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM2000 5166297

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other