BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFIBRILLATION LEAD

    MDR report key: 6092445 · Received November 10, 2016

    Report

    Report Number
    2938836-2016-14003
    Event Type
    Death
    Date Received
    November 10, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPDATE RV LEAD MODEL/SN FROM UNKNOWN TO (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED POST IMPLANT PROCEDURE. THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE PATIENT EXPIRED IN THE HOSPITAL; THE CAUSE DEATH WAS ASYSTOLE, BRADYCARDIA ARREST. THE PATIENT HAD ONE EPISODE OF CARDIAC ARREST 7 DAYS BEFORE DEATH AND 3 EPISODES OF SEVERE ASYSTOLE/BRADYCARDIA AFTER DEVICE IMPLANT. ACCORDING TO THE PHYSICIAN, PATIENT DEATH WAS NOT RELATED TO DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743183 DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7170/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CD2235-40,1200140| RV LEAD, UNK SERIAL#