BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTECTA XT CRT-D

    MDR report key: 3033433 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04556
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. (B)(4). CONCOMITANT PRODUCTS: 6947 IMPLANTABLE TACHY LEAD IMPLANTED 2008 (B)(6); 4193 IMPLANTABLE PACING LEAD IMPLANTED 2008 (B)(6); 4076 IMPLANTABLE PACING LEAD IMPLANTED 2008 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED AND DIED APPROXIMATELY SIX MONTHS POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) . ADDITIONAL INFORMATION NOTED, THE PATIENT WAS FOUND BY THE PATIENT'S SPOUSE, EMERGENCY SERVICES WERE CALLED AND RESUSCITATION EFFORTS WERE INITIATED. THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM WHERE THE PATIENT WAS PRONOUNCED DEAD. IT WAS FURTHER REPORTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED FOR TWO OR MORE HIGH RATE NON-SUSTAINED EPISODES OF VENTRICULAR TACHYCARDIA AND RIGHT VENTRICULAR LEAD OVERSENSING WAS PRESENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137263 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 00063 YR Death