BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR AT

    MDR report key: 1726377 · Received June 17, 2010

    Report

    Report Number
    6000094-2010-01418
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    March 21, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THE CAUSE OF DEATH HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. THERE WAS NO INDICATION THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A COUPLE OF "OFF" DAYS DURING THE WEEK PRIOR TO HIS DEATH, BUT HAD BEEN FEELING RELATIVELY WELL. HE WENT TO BED IN HIS SLEEPING CHAIR THE EVENING OF (B) (6) 2010. HIS WIFE AWOKE TO FIND HIM DECEASED IN HIS CHAIR. A TRANSMISSION FROM THE CARELINK MONITOR REVEALED THE DEVICE HAD TREATED VENTRICULAR ARRHYTHMIAS WITH BOTH ATP (ANTITACHYCARDIA PACING) AND SHOCKS AT APPROXIMATELY 2:39 AM, (B) (6) 2010. ATP WAS INITIALLY SUCCESSFUL, BUT THE PATIENT REVERTED TO VT (VENTRICULAR TACHYCARDIA), FOLLOWED BY VF (VENTRICULAR FIBRILLATION). THE FINAL SHOCK WAS UNSUCCESSFUL AND THE PATIENT DECEASED. THE DEVICE WAS REPORTEDLY DISCARDED, THERE WAS NO AUTOPSY PLANNED. THE CAUSE OF DEATH WAS REQUESTED BUT NOT RECEIVED. THERE WAS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL INDICATING THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR AT IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. C174AWK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 4396 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD