BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTIFICIAL URINARY SPHINCTER

    MDR report key: 271131 · Received March 22, 2000

    Report

    Report Number
    2183959-2000-00011
    Event Type
    Death
    Date Received
    March 22, 2000
    Date of Event
    July 30, 1999
    Report Date
    March 22, 2000
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION REC'D ON 2/24/2000, INDICATES AN EVENT REGARDING THE EXPIRATION OF A PT IN THE UK WITH AN AUS. IT APPEARS AN AUS DEVICE WAS IMPLANTED, PT NAME, DATE OF SURGERY, AND OTHER PERTINENT SURGICAL DETAILS WERE NOT INDICATED AT THIS TIME. THE REASON FOR THE PT'S INITIAL ADMISSION TO THE HOSP WAS NOT INDICATED. APPARENTLY THE PT WAS CATHETERIZED WITH THE AUS ACTIVATED CAUSING INJURY TO THE URETHRA. THE PT SUBSEQUENTLY DEVELOPED AN INFECTION AND DIED. IT IS UNCERTAIN WHICH, IF ANY, COMPONENTS WERE REVISED. AMS HAS REQUESTED ADD'L INFO.

    Description of Event or Problem · 1

    PT WAS ADMITTED WITH A LEAK FROM PERINEUM. PT HAD PREVIOUSLY UNDERGONE AN AP RESECTION IN MERTHYR TYDFIL FOR RECTAL CANCER. DURING THIS PROCEDURE, A HOLE HAD BEEN MADE IN THE PROSTATE, PROBABLE RELATED TO PREVIOUS PROSTATITIS MAKING THE DISSECTION DIFFICULT. THIS RESULTED IN A URETHROCUTANEOUS FISTULA. UNFORTUNATELY THERE IS A COMPLICATION OF THAT INDWELLING URETHRAL CATHETER WHICH HAD BEEN PLACED BY THE GENERAL SURGEONS, WHICH ERODED THE ARTIFICIAL URINARY SPHINCTER AND HAS HAD TO BE REMOVED. THIS PROCEDURE WENT UNEVENTFUL BUT DID MAKE PT'S INCONTINENCE MUCH WORST GIVEN THAT PT HAS AN INCOMPETENT BLADDER NECK. PT WAS DISCHARGED HOME WITH A SIGNIFICANT LEAK FROM THE PERINEUM. PT WAS RE-ADMITTED APPROX A WEEK LATER WITH GRAM NEGATIVE SEPTICAEMIA. THE PERINEAL FISTULA WAS RE-OPENED AND IT WAS HOPED THAT GIVEN THIS THE SEPSIS WOULD SETTLE. UNFORTUNATELY DESPITE DOUBLE ANTIBIOTIC COVER PT DEVELOPED ARDS AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. AT THAT POINT, IT WAS DOCUMENTED THAT PT HAD A MULTI-DRUG RESISTANCE SERRATIA GROWING IN THE URINE AND DESPITE APPROPRIATE ANTIBIOTIC THERAPY IMIPENEM, PT BECAME INCREASINGLY UNWELL. PT WAS TAKEN TO THEATRE AND HAD AN ILEAL CONDUIT PERFORMED TO TRY AND DIVERT THE URINARY STREAM IN THE HOPE THAT THIS WOULD SETTLE THE SEPSIS. THE SEPSIS PERSISTED AND THE PT HAD A TRACHIOSTOMY PLACED. THE FOLLOW-UP SCAN SHOWED ABSCESSES WITHIN THE SPLEEN AND PT WAS TAKEN BACK TO THEATRE AND HAD A SPLENECTOMY IN AN EFFORT TO SETTLE THE SEPSIS. DESPITE SHOWING INITIAL IMPROVEMENT FOLLOWING THE SPLENECTOMY, PT DETERIORATED AND DIED FROM RESPIRATORY COMPLICATIONS RELATED TO ARDS. THE OUTCOME UNFORTUNATELY WAS DISTRESSING GIVEN THE FACT THAT AT TIMES PT APPEARED TO HAVE RALLIED AND THAT THE SEPSIS JUST DEVELOPED TERRIBLE ARDS RELATED TO THE UROSEPSIS. FURTHER, DESPITE WHAT WOULD HAVE BEEN REASONABLE ANTIBIOTIC COVER GIVEN THE PREVIOUS URINE MICROSCOPY, THIS WAS UNDONE BY THE PARTICULAR ORGANISM THAT PT WAS CARRYING AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTIFICIAL URINARY SPHINCTER AUS EZY AMERICAN MEDICAL SYSTEMS, INC. AUS BF291 009, BL742 001,BT244 008

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H| R