BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA CRT-D

    MDR report key: 2213469 · Received August 16, 2011

    Report

    Report Number
    2647346-2011-01097
    Event Type
    Death
    Date Received
    August 16, 2011
    Date of Event
    January 23, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PATIENT ALERT FOR LEAD FAILURE PREDICTOR OCCURRED ON (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED AND DIED FIVE DAYS POST IMPLANTABLE CARDIAC DEFIBRILLATOR REPLACEMENT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death 4543 COMPETITOR IMPLANTABLE PACING LEAD| 4543 COMPETITOR IMPLANTABLE PACING LEAD