BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6054768 · Received October 25, 2016

    Report

    Report Number
    2938836-2016-12934
    Event Type
    Death
    Date Received
    October 25, 2016
    Report Date
    September 27, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT DEVICE WAS FUNCTIONING APPROPRIATELY DURING THE PATIENT LAST FOLLOW-UP VISIT ON (B)(6) 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE PATIENT EXPIRED ON JUNE 2, 2016 DUE TO A CARDIAC ARREST. SHE IS CONCERNED THAT THERE MAY HAVE BEEN AN ISSUE WITH THE TRANSMISSION(S) AND/OR THE FUNCTION OF THE ICD. THE ICD WAS EXPLANTED AND WAS INTERROGATED AFTER THE PATIENT PASSING. THE PHYSICIAN ALLEGEDLY REPORTED "FAINT HANDSHAKE" BETWEEN THE DEVICE AND TRANSMITTER AND THAT THERE WAS INTERMITTENT COMMUNICATION WITH THE TRANSMITTER SINCE IMPLANT. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705434 OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) LDA210Q/58 A000005234

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)| (B)(4)| (B)(4)| (B)(4)