BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMX 700 CX

    MDR report key: 3220884 · Received July 8, 2013

    Report

    Report Number
    3220884
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    JCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    PENILE PROSTHESIS FAILED, SURGICALLY REMOVED IN OR. PATIENT HAS A HISTORY OF RECTAL CANCER S/P RESECTION INCLUDING PARTIAL CYSTECTOMY DUE TO INVASION OF RECTAL CANCER INTO BLADDER, PERMANENT COLOSTOMY AND INFLATABLE PENILE PROSTHESIS (IPP) PLACEMENT. INITIAL IPP PLACED ABOUT 11 YEARS AGO, REPORTS THAT THERE WAS A LEAD AND THE PROSTHESIS FAILED AND THEREFORE IT WAS REMOVED AND REPLACED ABOUT 5 YEARS AGO. OPERATIVE NOTE INDICATES THAT HE CURRENTLY HAS AN AMS 700 CX IMPLANT IN PLACE.NOTES THAT THE PROSTHESIS WORKED GREAT INITIALLY AND THAT IN THE LAST 6 MONTHS HE HAS NOTICED THAT HIS PENIS CURVES TO THE RIGHT, GREATER WHEN THE PROSTHESIS IS INFLATED. DENIES KNOWN TRAUMA OR VIGOROUS SEXUAL ACTIVITY THAT PRECIPITATED THE CURVATURE. IN THE OR: DEVICE WAS PUMPED UP AND VEERING QUITE A BIT TO THE RIGHT. CORPOROTOMY WAS PERFORMED AND IT WAS EVIDENT ON BOTH SIDES THAT WE FIRST ENCOUNTERED THE MIDDLE DACRON LAYER, THE CYLINDER INDICATING LOSS OF CONTAINMENT OF THE EXTERNAL SILICONE SHEATH. NEVERTHELESS, WE WERE ABLE TO IDENTIFY THE FRAYED EDGE OF THE SILICONE SHEATH ON THE RIGHT SIDE AND RATHER EASILY PULLED THIS DEVICE OUT. ON THE LEFT SIDE, THE DACRON WAS STUCK TO SURROUNDING TISSUE AND REQUIRED A FAIR AMOUNT OF FORCE TO PULL OUT. WE KNEW FROM PREVIOUS RECORDS THAT THIS WAS AN AMS 700 DEVICE WITH 21 CENTIMETERS CYLINDERS AND 7 CENTIMETERS REAR TIP EXTENDERS ON THE RIGHT AND SIX ON THE LEFT. ONCE REMOVING THE COMPONENTS, ALL REAR TIP EXTENDERS WERE IDENTIFIED. THERE WAS TEFLON PRESENT BUT HAD BEEN INCORPORATED COMPLETELY WITHIN THE CORPOROTOMY CREATING A SITUATION OF SILICONE TUBING RUBBING ON THE SILICONE OUTER SHEATH, POSSIBLY THE REASON FOR THE BREECH OF THE SILICONE OUTER SHEATH. ONCE PULLING THE DEVICE OUT, WE WERE ABLE TO REDUCE THE SILICONE SHEATH WHICH HAD ACCORDIONED DOWN THE CORPORAL BODIES, MORE ON THE LEFT THAN THE RIGHT AND IT APPEARED THAT ALL COMPONENTS OF THE OUTER SILICONE SHEATH WERE ACCOUNTED FOR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?INFLATABLE PENILE PROSTHESIS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312074 AMX 700 CX PROSTHESIS, PENILE JCW AMERICAN MEDICAL SYSTEMS AMX 700 CX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR