BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 38108 · Received September 11, 1996

    Report

    Report Number
    1219454-1996-00406
    Event Type
    Death
    Date Received
    September 11, 1996
    Date of Event
    September 9, 1995
    Report Date
    September 11, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    MDY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ON 8/16/96, THE MFR RECEIVED THE FOLLOWING RESPONSE TO A DEVICE TRACKING POLLING LETTER FROM THE PT'S FAMILY: "TO WHOM IT MAY CONCERN: THE PT PASSED AWAY ON 9/9/95, FOLLOWING ININSERTION OF THE MFR'S DEVICE AND COMPLICATIONS THERE OF. BE INFORMED THE FAMILY WAS NOT MADE AWARE OF THE TYPE OF DEVICE THIS WAS. THERE WILL BE NO SIGNING OF CONSENT. IF YOU WISH DETAILS, CONTACT THE PHYSICIAN WHO DID THIS!" SIGNED THE FAMILY OF THE PT. ON 8/16/96, A MFR REP CONTACTED A DR FROM THE IMPLANTING DR'S FACILITY. THE DR REVIEWED THE PT'S FILE/RECORD AND STATED THAT THIS EVENT WAS DUE TO THE PT'S CONDITION, NOT DUE TO THE DEVICE OR DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSAID IMPLANTABLE INFUSION PUMP Implant IMPLANTABLE INFUSION PUMP MDY STRATO/INFUSAID, INC. 400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death