BEUDAMED
    FDA Adverse Event Death Summary report: N

    EVERA MRI DR

    MDR report key: 6204942 · Received December 27, 2016

    Report

    Report Number
    3004209178-2016-27179
    Event Type
    Death
    Date Received
    December 27, 2016
    Date of Event
    September 12, 2016
    Report Date
    December 2, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LWS
    UDI-DI
    00643169314092
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED WITH (B)(6). 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 (B)(6) STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857139 EVERA MRI DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO. DDMB1D4 00643169314092

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death 6935M55 LEAD, 5086MRI45 LEAD