BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY DR, U1.6 DF1 ID

    MDR report key: 4917754 · Received July 16, 2015

    Report

    Report Number
    3010215456-2015-27980
    Event Type
    Death
    Date Received
    July 16, 2015
    Date of Event
    May 16, 2015
    Report Date
    July 15, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC. (CRM-KISTA)
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MERLIN.NET TRANSMISSION FOR A VF EVENT INDICATED NON-PHYSIOLOGICAL NOISE. THE PATIENT HAD NO INAPPROPRIATE THERAPY BUT WAS ADMITTED TO HOSPITAL FOR FURTHER INVESTIGATION. DURING LEAD EXPLANT THERE WERE COMPLICATIONS DURING THE EXTRACTION AND THERE WAS SUBSTANTIAL TISSUE INGROWTH IN THE SVC COIL WHICH LED TO SEVERE DAMAGE. THE PATIENT¿S CHEST WAS OPENED AS AN EMERGENCY. THE PATIENT LATER ON PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462014 FORTIFY DR, U1.6 DF1 ID IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC. (CRM-KISTA) CD2233-40 3664817

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 1580 RIATA, UNK (B)(4)