BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1659692 · Received April 15, 2010

    Report

    Report Number
    2647346-2010-00140
    Event Type
    Death
    Date Received
    April 15, 2010
    Date of Event
    February 16, 2010
    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

    (B) (4)

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED AND THE PARAMEDICS REPORTED THAT "DEVICE MALFUNCTIONED." THE PHYSICIAN BELIEVES THE PATIENT WAS IN A VENTRICULAR TACHYCARDIA BELOW THE PROGRAMMED CUT OFF RATE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PARAMEDIC'S STATEMENT REGARDING DEVICE MALFUNCTIONING HAD BEEN MISUNDERSTOOD. THE PATIENT'S WIFE, WHO WAS A NURSE, NOTED THERE WERE NO PACING SPIKES ON THE MONITOR WHEN THE PATIENT WAS CONNECTED AND MADE A COMMENT TO THE PARAMEDIC. THE ONLY INFORMATION THE PHYSICIAN HAD WAS THAT THE DEVICE CALLED THE LAST EPISODE "TERMINATED, BUT THE EGM LOOKED LIKE HE WAS STILL IN A SLOW VT."

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED AND THE PARAMEDICS REPORTED THAT "DEVICE MALFUNTIONED." THE PHYSICIAN BELIEVES THE PATIENT WAS IN A VENTRICULAR TACHYCARDIA BELOW THE PROGRAMMED CUT OFF RATE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DIED AND THE PARAMEDICS REPORTED THAT "DEVICE MALFUNCTIONED." THE PHYSICIAN BELIEVES THE PATIENT WAS IN A VENTRICULAR TACHYCARDIA BELOW THE PROGRAMMED CUT OFF RATE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PARAMEDIC'S STATEMENT REGARDING DEVICE MALFUNCTIONING HAD BEEN MISUNDERSTOOD. THE PATIENT'S WIFE, WHO WAS A NURSE, NOTED THERE WERE NO PACING SPIKES ON THE MONITOR WHEN THE PATIENT WAS CONNECTED AND MADE A COMMENT TO THE PARAMEDIC. THE ONLY INFORMATION THE PHYSICIAN HAD WAS THAT THE DEVICE CALLED THE LAST EPISODE "TERMINATED, BUT THE EGM LOOKED LIKE HE WAS STILL IN A SLOW VT."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| O 6945 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD