BEUDAMED
    FDA Adverse Event Death Summary report: N

    SECURA DR

    MDR report key: 2230067 · Received August 31, 2011

    Report

    Report Number
    2647346-2011-01142
    Event Type
    Death
    Date Received
    August 31, 2011
    Date of Event
    July 30, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRECTION HAS BEEN ON THE DEVICE (B)(4) AND THE MONITOR (B)(4). FURTHER INVESTIGATION REGARDING THE COMPLAINT OF THE MISSED CAREALERT WAS COMPLETED. REVIEW OF THE ICD DEVICE INFORMATION FOR THE PATIENT REVEALED ALTHOUGH THE PATIENT HAD A VT/VF EPISODE, THE ALERT FOR VT/VF EPISODE WAS PROGRAMMED OFF, WHICH MEANS EVEN THOUGH THE PATIENT HAD EPISODES, THE MONITOR WOULD NOT TRANSMIT BECAUSE THE ALERT IS NOT ENABLED. OF FURTHER NOTE REGARDING THE ALERT RECEIVED ON (B)(6) 2011, THE PATIENT HAD A LIA ALERT TRIGGER WHICH WAS TIMELY. CONSEQUENTLY THIS HAS PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT UNDER SECTION. CONCLUSION CODEATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINIC THAT THEY DID NOT RECEIVE AN ALERT FROM THE REMOTE MONITOR UNTIL APPROXIMATELY TWO DAYS AFTER THE PATIENT HAD DIED, AS REPORTED BY THE PATIENT'S FAMILY MEMBER. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY ELEVEN MONTHS POST OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINIC THAT THEY DID NOT RECEIVE AN ALERT FROM THE REMOTE MONITOR UNTIL APPROXIMATELY TWO DAYS AFTER THE PATIENT HAD DIED, AS REPORTED BY THE PATIENT'S FAMILY MEMBER. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY ELEVEN MONTHS POST OF THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) SYSTEM. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death