BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERITY ADX SR

    MDR report key: 6131823 · Received November 29, 2016

    Report

    Report Number
    2017865-2016-07388
    Event Type
    Death
    Date Received
    November 29, 2016
    Date of Event
    September 24, 2016
    Report Date
    November 1, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNDER PALLIATIVE CARE AND DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NEW INFORMATION REPORTED STATED THAT THE PATIENT DEVELOPED ENDOCARDITIS.

    Description of Event or Problem · 1

    NEW INFORMATION REPORTED STATED THAT THE PATIENT'S WIFE REPORTED THAT THE PATIENT WENT TO THE HOSPITAL IN 2014 WITH INFECTIVE ENDOCARDITIS, FAMILY WERE NOT TOLD THE SOURCE OF THIS INFECTION. PATIENT SPENT 8 WEEKS IN HOSPITAL ON DRIP WITH ANTIBIOTICS, PATIENT RECOVERED BUT WAS NEVER QUITE THE SAME FOLLOWING THIS, LIMITED MOBILITY BUT SOME QUALITY OF LIFE. PLACED INTO NURSING HOME SHORTLY AFTER BEING DISCHARGED FROM HOSPITAL. PACEMAKER SET TO 85 BEATS TO TRY AND REMOVE WATER RETENTION. RATE NOT CHECKED AGAIN BY THE HOSPITAL UNTIL PATIENT'S DEATH. TO HELP GFR RATE, HOSPITAL TOOK PATIENT OFF MEDICATION FOR GOUT AND 1 OTHER PHARMACEUTICAL BUT PACEMAKER RATE NEVER ADJUSTED, GFR PLATEAUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784063 VERITY ADX SR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 5156 3114609

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death