BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 6172116 · Received December 13, 2016

    Report

    Report Number
    3004209178-2016-26391
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    May 21, 2015
    Report Date
    November 14, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    UDI-DI
    00613994677884
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2012. 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

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THE PATIENT PRESENTED TO THE HOSPITAL WITH EROSION OF THE WIRES INTO THE CHEST WALL AND IT WAS DETERMINED THE PATIENT DEVELOPED A POCKET INFECTION. A RECOMMENDATION WAS MADE FOR HOSPITAL ADMISSION; HOWEVER, THE PATIENT DECLINED AND ADMISSION WAS DELAYED. WHEN THE PATIENT WAS ULTIMATELY ADMITTED IT WAS DETERMINED THERE WAS VEGETATION ON THE TRICUSPID VALVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO VEGETATION AND THE PATIENT IS DECEASED. A REQUEST FOR ADDITIONAL INFORMATION REVEALED THE CAUSE OF DEATH WAS SEPSIS, MULTI SYSTEM ORGAN FAILURE, RENAL FAILURE, AND ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822974 PROTECTA XT CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314TRG 00613994677884

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death| H| R 6944-65 LEAD, 5554-53 LEAD