BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1840768 · Received September 22, 2010

    Report

    Report Number
    2647346-2010-00525
    Event Type
    Death
    Date Received
    September 22, 2010
    Date of Event
    July 15, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S031
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION TO THE DATE OF DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS COMPLETELY PACEMAKER DEPENDENT. THE ATRIAL LEAD DID NOT SENSE OR CAPTURE AND THE RV LEAD WAS FRACTURED. THE PATIENT HAD SVC STENOSIS. THE LEADS AND THE DEVICE WERE REPLACED. IT WAS LATER REPORTED BY THE NURSE THAT SHE HAD BEEN MADE AWARE THE PATIENT HAD DIED AND WAS QUESTIONING "WHETHER IT WAS FROM THE SF-LEAD REPLACEMENT." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH HEALTH CARE PROFESSIONAL REVEALED THE PATIENT HAD BEEN "ASYSTOLIC" AND THE WIFE HAD REPORTED TO THEM THAT PATIENT DIED FROM A HEART ATTACK. LATER REPORTED PATIENT HAD WITNESSED ARREST BY FAMILY WITH NO BYSTANDER CPR PERFORMED. EMS REPORTED PATIENT IN VT AND NEVER REGAINED PULSES. ER RECORD REPORTS INITIAL RHYTHM WAS PEA. DEFIBRILLATION NOT PERFORMED BY THEM, AN EXTERNAL PACER WAS EMPLOYED WITH NO RESPONSE. PATIENT REMAINED IN ARREST AND EVENTUALLY WAS PRONOUNCED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS COMPLETELY PACEMAKER DEPENDENT. THE ATRIAL LEAD DID NOT SENSE OR CAPTURE AND THE RV LEAD WAS FRACTURED. THE PATIENT HAD SVC STENOSIS. THE LEADS AND THE DEVICE WERE REPLACED. IT WAS LATER REPORTED BY THE NURSE THAT SHE HAD BEEN MADE AWARE THE PATIENT HAD DIED 19 DAYS LATER AND SHE WAS QUESTIONING "WHETHER IT WAS FROM THE SF-LEAD REPLACEMENT." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS COMPLETELY PACEMAKER DEPENDENT. THE ATRIAL LEAD DID NOT SENSE OR CAPTURE AND THE RV LEAD WAS FRACTURED. THE PATIENT HAD SVC STENOSIS. THE LEADS AND THE DEVICE WERE REPLACED. IT WAS LATER REPORTED BY THE NURSE THAT SHE HAD BEEN MADE AWARE THE PATIENT HAD DIED AND WAS QUESTIONING "WHETHER IT WAS FROM THE SF-LEAD REPLACEMENT." THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH HEALTH CARE PROFESSIONAL REVEALED THE PATIENT HAD BEEN "ASYSTOLIC" AND THE WIFE HAD REPORTED TO THEM THAT PATIENT DIED FROM A HEART ATTACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR ASKU NIK MEDTRONIC MED REL, INC. C154DWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| L| R