BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 6156758 · Received December 8, 2016

    Report

    Report Number
    2649622-2016-13905
    Event Type
    Death
    Date Received
    December 8, 2016
    Date of Event
    September 12, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MPRI
    Product Code
    NVN
    UDI-DI
    00613994657350
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED WITH (B)(6) BACTEREMIA AND SEPSIS. THE PATIENT ALSO DEVELOPED MITRAL VALVE ENDOCARDITIS INVOLVING A MITRAL VALVE ANNULOPLASTY RING. THE PATIENT WAS TREATED WITH ANTIBIOTICS. DURING EXPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM, THE PATIENT DEVELOPED BRADYCARDIA AND HYPOTENSION AND THERE WERE ¿RUNS¿OF VENTRICULAR TACHYCARDIA (VT). THE PATIENT WENT INTO CARDIOGENIC SHOCK, RENAL AND LIVER FAILURE AND WAS PLACED ON A VENTILATOR. THE PATIENT REMAINED IN SHOCK AND WAS UNABLE TO BE ¿WEANED¿ FROM THE PHENYLEPHRINE AND EPINEPHRINE DRIPS. BASED ON THE PROGNOSIS THE DECISION WAS MADE TO WITHDRAW CARE AND THE PATIENT EXPIRED. THE PATIENT WAS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806197 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI45 00613994657350

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death DDMB1D4 ICD, 6935M55 LEAD