BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II CRT-D

    MDR report key: 2130861 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01275
    Event Type
    Death
    Date Received
    June 16, 2011
    Date of Event
    November 17, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE CAUSE OF DEATH IS ACUTE PULMONARY EDEMA. IN (B)(6) 2007, THE PATIENT SUFFERED A MYOCARDIAL INFARCTION. IN (B)(6) 2008, THE PATIENT SUFFERED ANOTHER ANTERIOR WALL MYOCARDIAL INFARCTION. FOLLOWING DISCHARGE, THE PATIENT WAS HOSPITALIZED A NUMBER OF TIMES IN FOR CONGESTIVE PROBLEMS. IN (B)(6) 2010 THE IMPLANTATION OF ICD-D IS INDICATED AND PERFORMED SEVEN DAYS PRIOR TO DEATH. THE INDICATION FOR THE IMPLANT WAS COMPLETE LEFT BUNDLE BRANCH HEART BLOCK. PARAMETERS WERE CHECKED, CRT-D BATTERY CONNECTED AND PLACED INTO THE PREFORMED POUCH. NORMAL FUNCTION [CONFIRMED]. WOUND SUTURED AND A BANDAGE PLACED. INTERVENTION PERFORMED WITHOUT COMPLICATIONS. CS LEAD MEDTRONIC (B)(4), THRESHOLD 0.6 V; R 8.0 MV; IMP 1112 OHM. THE PATIENT IS DISCHARGED INTO FURTHER OUTPATIENT FOLLOW-UP CARE. THERAPY IS PRESCRIBED AND PATIENT EDUCATION CONDUCTED WITH RESPECT TO DIET AND LIFESTYLE. THE PATIENT DIED SEVEN DAYS LATER. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH AN IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR DIED SEVEN DAYS AFTER IMPLANT. THE PATIENT HAD HEART FAILURE WITH ACUTE PULMONARY EDEMA. THE PATIENT WAS HAVING BREATHING DIFFICULTIES PRIOR TO THE DEATH AND AN AMBULANCE WAS CALLED. THE PATIENT DIED BEFORE IT ARRIVED. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D284TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death