BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT DR

    MDR report key: 9451596 · Received December 11, 2019

    Report

    Report Number
    3004209178-2019-23594
    Event Type
    Death
    Date Received
    December 11, 2019
    Date of Event
    October 12, 2019
    Report Date
    December 11, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    UDI-DI
    00613994714572
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: MODEL: (B)(4) LEAD; IMPLANTED: (B)(6) 2012. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO WORSENING SHORTNESS OF BREATH AND PROGRESSIVE LOWER EXTREMITY EDEMA WITH ACUTE CARDIOGENIC PULMONARY EDEMA, ACUTE HYPOXEMIC RESPIRATORY FAILURE ON NASAL INTERMITTENT POSITIVE PRESSURE VENTILATION (NIPPV) SECONDARY, ACUTE ON CHRONIC SYSTOLIC AND DIASTOLIC HEART FAILURE, NON-ISCHEMIC CARDIOMYOPATHY, ACUTE ON CHRONIC KIDNEY INJURY CARDIORENAL SYNDROME. MULTI SYSTEM ORGAN FAILURE, HOSPITALIZED RECENTLY FOR DECOMPENSATED HEART FAILURE WITH REPEAT TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWING DECREASE IN LEFT VENTRICULAR EJECTION FRACTION (LVEF) FROM 29% TO 20%. THE PATIENT REPORTS PAROXYSMAL NOCTURNAL DYSPNEA (PND), AND ORTHOPNEA. SINCE ADMISSION THE PATIENT DEVELOPED FEVER AND HYPOTENSION WITH BLOOD CULTURE GROWING (B)(6) AND TEE SHOWING TRICUSPID VALVE (TV) ENDOCARDITIS (TTE NEGATIVE) AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD VEGETATION. WORSENING RENAL FUNCTION REQUIRING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT), CARDIOGENIC SHOCK, END STAGE NON-ISCHEMIC CARDIOMYOPATHY, SEPTIC SHOCK AND SHOCK LIVER. SHOCK STATE TRANSIENTLY IMPROVED BUT CLINICAL STATUS SIGNIFICANTLY WORSENED WITH INCREASING VASOPRESSOR REQUIREMENTS AND WORSENING EDEMA DESPITE CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH). THE PATIENT DIED DESPITE ALL EFFORTS AND SUPPORTIVE TREATMENT. THE PATIENT WAS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249144 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRM 00613994714572

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death (B)(4) LEAD.