BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLIA MRI QUAD CRT-D

    MDR report key: 6195990 · Received December 21, 2016

    Report

    Report Number
    3004209178-2016-27000
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 30, 2016
    Report Date
    November 30, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    NIK
    UDI-DI
    00643169543386
    PMA / PMN Number
    P010031
    Removal / Correction Number
    Z-0962-2017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS REPORTED AS INCLUDED IN THE FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF THE PRODUCT, IT CANNOT BE CONFIRMED THAT THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. IT IS INCLUDED IN THE FIELD ACTION IN THE ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S EXISTING PACEMAKER SYSTEM WAS EXTRACTED FROM THEIR RIGHT SIDE AND A NEW CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS IMPLANTED ON THEIR LEFT. OVER THE COURSE OF THE NEXT HOUR, THE ANESTHESIA TEAM WORKED TO EXTUBATE THE PATIENT. CARDIAC ACTIVITY CEASED DURING THAT PROCESS. AFTER TWO HOURS OF ATTEMPTING TO REVIVE THE PATIENT, THEY WERE PRONOUNCED DEAD. THE CAUSE OF DEATH IS UNCLEAR. FOLLOW UP YIELDED NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843011 AMPLIA MRI QUAD CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC PUERTO RICO OPERATIONS CO. DTMB1QQ 00643169543386

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death 6935M LEAD, 5076 LEAD, 4298 LEAD