BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC III

    MDR report key: 1735506 · Received June 24, 2010

    Report

    Report Number
    6000094-2010-01420
    Event Type
    Death
    Date Received
    June 24, 2010
    Date of Event
    April 15, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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. IT WAS LATER REPORTED BY THE PATIENT'S MOTHER THAT ON (B) (6)-2010, THE PATIENT WAS WORKING AND FELL DOWN FROM HIS CHAIR BEHIND THE DESK AND HIS HEART STOPPED. WHEN PARAMEDICS ARRIVED, PEA WAS CONFIRMED AND THE PATIENT RECEIVED TWO EXTERNAL SHOCKS FOR VENTRICULAR FIBRILLATION. THEY WORKED ON PATIENT FOR 30 MINUTES AFTER WHICH SINUS RHYTHM APPEARED. HE WAS ADMITTED INTO THE INTENSIVE CARE UNIT. THERE WAS INDICATION OF NEED TO UPGRADE TO AN ICD. BASED ON CT SCAN, IT WAS SUSPECTED THE PATIENT SUFFERED SEVERE ISCHEMIC HEART DAMAGE IN CONNECTION WITH THE CARDIAC ARREST ALONG WITH SIGNIFICANT BRAIN DAMAGE. IT WAS FURTHER REPORTED THE PATIENT WAS RECEIVING ANTIBIOTICS FOR COMPLICATING INFECTION/PNEUMONIA. RHYTHM WAS NOTED TO BE "MOST PACED VIA THE BIVENTRICULAR PACEMAKER". ON (B) (6)-2010, THE PATIENT WAS MADE "DO NOT RESUSCITATE (DNR)". THE PATIENT DIED ON (B) (6)-2010. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Description of Event or Problem · 1

    IT HAD BEEN REPORTED THAT ON (B) (6)-2008, PATIENT HAD WORSENING HEART FAILURE AND DYSPNEA. IT WAS ALSO REPORTED BY THE MANUFACTURER'S REPRESENTATIVE, "DUE TO INCREASED LEFT VENTRICULAR LEAD THRESHOLD, THEY CANNOT GUARANTEE THAT THERE HAS BEEN CAPTURE ALL THE TIME; THEREFORE, THEY CANNOT RULE OUT THE WORSENING HF WAS NOT DUE TO LACK OF LEFT VENTRICULAR CAPTURE". THE LEFT VENTRICULAR LEAD REMAINED IN USE BECAUSE IT WAS FELT THE LEAD WAS "WORKING PROPERLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death