BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 2844798 · Received November 26, 2012

    Report

    Report Number
    3004209178-2012-10733
    Event Type
    Death
    Date Received
    November 26, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 30, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. (B)(4). CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD 2012 (B)(6); 6947 IMPLANTABLE TACHY LEAD 2010 (B)(6). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT IS DECEASED AND DIED THREE DAYS POST IMPLANT OF IMPLANTABLE CARDIAC DEFIBRILLATOR SYSTEM. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Death 4196 IMPLANTABLE PACING LEAD