BEUDAMED
    FDA Adverse Event Death Summary report: N

    IPERIA 7 DR-T DF4 PROMRI

    MDR report key: 6137966 · Received December 1, 2016

    Report

    Report Number
    1028232-2016-04799
    Event Type
    Death
    Date Received
    December 1, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 21, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE INFORMATION YOU PROVIDED HAS BEEN ENTERED INTO OUR QUALITY SYSTEM AS A COMPLAINT. THESE TYPES OF COMPLAINTS ARE USED TO EVALUATE SYSTEMS AND DEVICE PERFORMANCE THROUGHOUT OUR ORGANIZATION AND HELP TO MAINTAIN AND IMPROVE THE PERFORMANCE OF OUR DEVICES. SHOULD ADDITIONAL RELEVANT INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE, THE INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO SEPTIC SHOCK SECONDARY TO PNEUMONIA. EVER SINCE THEN THE PATIENT HAS NOT BEEN DOING WELL, HAD POOR APPETITE, GENERALIZED WEAKNESS. IN THE AFTERNOON OF (B)(6) 2016 HE DEVELOPED INTERMITTENT DRENCHING SWEATS AND DYSPNEA, THAT BECAME SIGNIFICANTLY WORSE AFTER THE PATIENT THREW UP. ON PRESENTATION TO THE EMERGENCY ROOM, THE PATIENT WAS PROFOUNDLY HYPOTENSIVE, HYPOXEMIC, DIDN'T IMPROVE CARDIOPULMONARY STATUS AFTER BEING INITIATED ON MAXIMUM DOSE OF CONTINUOUS IV INFUSION OF DOPAMINE AND VENTILATORY SUPPORT VIA BIPAP. IMAGING STUDIES DEMONSTRATED BILATERAL PULMONARY EDEMA AND EFFUSIONS URINALYSIS WAS C/W UTI. LABORATORY STUDIES REVEALED ELEVATED PROBNP, PROCALCITONIN AND WORSENING IN KIDNEY FUNCTION. THE PATIENTS FAMILY REQUESTED DISCONTINUATION INITIATED IN THE ER VENTILATORY AND PRESSOR SUPPORT AND TRANSITION TO COMFORT MEASURES ONLY. THE PATIENT DIED IN THE ACUTE PALLIATIVE CARE UNIT ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790022 IPERIA 7 DR-T DF4 PROMRI ICD MRM BIOTRONIK SE & CO. KG 392423

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death| H