BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 6807448 · Received August 21, 2017

    Report

    Report Number
    2183959-2017-00075
    Event Type
    Death
    Date Received
    August 21, 2017
    Report Date
    July 24, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MINNETONKA
    Product Code
    FHW
    UDI-DI
    00878953003603
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL (B)(4), CATALOG # 72404156, EXPIRATION DATE: 02/24/2019, IMPLANT DATE: (B)(6) 2017. DEVICE MANUFACTURE DATE: 02/24/2019.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN INFLATABLE PENILE PROSTHESIS ORIGINAL IMPLANT SURGERY, WHEN THEY "WERE ATTEMPTING TO WAKE UP THE PATIENT, HE BEGAN COUGHING VERY BAD AND WAS NEVER ABLE TO WAKE UP AFTER SURGERY." THE PATIENT HAD DIFFICULTY WAKING UP FROM ANESTHESIA. THE PATIENT WAS TRANSPORTED ACROSS THE STREET TO THE HOSPITAL AT WHICH TIME HE EXPERIENCED AN "M I" AND DIED. IT APPEARS THE PATIENT WAS ILL WITH AN UNKNOWN ILLNESS AND HAD HIGH BLOOD SUGAR PRIOR TO THE IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587882 AMS INFLATABLE PENILE PROSTHESIS DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC - MINNETONKA 00878953003603

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death