BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HF SENSOR DELIVERY SYSTEM

    MDR report key: 9367167 · Received November 24, 2019

    Report

    Report Number
    3004936110-2019-00611
    Event Type
    Injury
    Date Received
    November 24, 2019
    Report Date
    November 24, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED HEMOPTYSIS REMAINS UNKNOWN. PER THE IFU, HEMOPTYSIS IS A KNOWN INHERENT RISK DURING A CARDIOMEMS SENSOR IMPLANT.

    Description of Event or Problem · 1

    OTHER RELATED MFR REPORT NUMBERS ARE: 3004936110-2019-00444, 3004936110-2019-00446, 3004936110-2019-00601, 3004936110-2019-00602, 3004936110-2019-00637, 3004936110-2019-00638, 3004936110-2019-00639, 3004936110-2019-00640, 3004936110-2019-00641, 3004936110-2019-00642, 3004936110-2019-00643. ONE CASE OF HEMOPTYSIS WAS REPORTED IN ASSOCIATION WITH A CMEMS SENSOR FROM THE LITERATURE ARTICLE BELOW. "MEASURES OF PROCEDURE SAFETY WERE IN-HOSPITAL AND 30-DAY MORTALITY AND IMPLANT COMPLICATIONS, INCLUDING ACCESS SITE HEMATOMA, PNEUMOTHORAX, PA INJURY/HEMOPTYSIS, AND INABILITY TO DEPLOY DEVICE. COMPLICATIONS, INCLUDING ONE CASE OF HEMOPTYSIS. THE OCCURRENCE OF HEMOPTYSIS WAS MINOR AND DID NOT REQUIRE INTERVENTIONS SUCH AS BRONCHOSCOPY, BLOOD TRANSFUSION, OR INTENSIVE CARE UNIT ADMISSION. INTERNAL JUGULAR VEIN AS ALTERNATIVE ACCESS FOR IMPLANTATION OF A WIRELESS PULMONARY ARTERY PRESSURE SENSOR. PUBLICATION INFO: CIRCULATION. HEART FAILURE 12.8: E006060. NLM (MEDLINE). (AUG 1, 2019).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161735 HF SENSOR DELIVERY SYSTEM IMPLANTABLE HF SENSOR AND DELIVERY SYSTEM MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM2000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention