BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8701435 · Received June 14, 2019

    Report

    Report Number
    2183959-2019-64125
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    August 12, 2019
    Report Date
    October 15, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER 72400152, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 578636006, MODEL/CATALOG DESCRIPTION RESERVOIR 65 ML, EXPIRATION DATE 12/23/2013, MANUFACTURER DATE 01/07/2009.

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS: DEVICE MALFUNCTION WAS REPORTED. THE AMS700 DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THERE WAS A LEAK IN BOTH CYLINDERS THAT WAS THE RESULT OF UNDETERMINED WEAR AND AVULSION. BOTH CYLINDERS HAD BROKEN FABRIC THREADS. THERE WAS A LEAK IN ONE PUMP CYLINDER KINK RESISTANT TUBING (KRT) AT THE PUMP STRAIN RELIEF JUNCTION DUE TO FATIGUE. THE PUMP WAS NOT FUNCTIONALLY TESTED DUE TO THE LEAK. THE IDENTIFIED LEAKS CONFIRM THE REPORTED MALFUNCTION OF STOPPED WORKING AS A FLUID LEAK WOULD RENDER THE DEVICE NON-FUNCTIONAL. BASED ON THE RESULTS OF THIS INVESTIGATION, NO ESCALATION IS REQUIRED. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, THE PRODUCT INVESTIGATION WILL BE REOPENED TO ADDRESS THE ADDITIONAL INFORMATION. RESERVOIR ANALYSIS: DEVICE MALFUNCTION WAS REPORTED. THE AMS700 RESERVOIR WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. NO LEAK WAS FOUND. IT PERFORMED WITHIN SPECIFICATIONS. NO DEVICE MALFUNCTION COULD BE CONFIRMED. THE INVESTIGATION CONCLUSION CODE OF NO PROBLEM DETECTED WAS CHOSEN BECAUSE THE REPORTED DEVICE COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO ESCALATION IS REQUIRED. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, THE PRODUCT INVESTIGATION WILL BE REOPENED TO ADDRESS THE ADDITIONAL INFORMATION. MODEL NUMBER/CATALOG NUMBER 72400152 SERIAL NUMBER (B)(4) BATCH/LOT NUMBER 578636006 MODEL/CATALOG DESCRIPTION RESERVOIR 65 ML EXPIRATION DATE 12/23/2013. H4 MANUFACTURER DATE 01/07/2009. ADDITIONAL INFORMATION: B5, D7, D10, E, H3, H6, H10. THE AMS700 DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THERE WAS A LEAK IN BOTH CYLINDERS THAT WAS THE RESULT OF UNDETERMINED WEAR AND AVULSION. BOTH CYLINDERS HAD BROKEN FABRIC THREADS. THERE WAS A LEAK IN ONE PUMP CYLINDER KINK RESISTANT TUBING (KRT) AT THE PUMP STRAIN RELIEF JUNCTION DUE TO FATIGUE. THE PUMP WAS NOT FUNCTIONALLY TESTED DUE TO THE LEAK. THE AMS700 RESERVOIR WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. NO LEAK WAS FOUND. IT PERFORMED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER ALMOST 10 YEARS, THE INFLATABLE PENILE PROSTHESIS JUST STOPPED WORKING. THE UROLOGIST IS GOING TO REMOVE THE PROSTHESIS, HOWEVER, THERE IS NOT YET A SCHEDULED DATE FOR SURGERY. SINCE THE PROSTHESIS HAS NOT BEEN REMOVED FROM THE PATIENT YET, HE IS OK. IT IS JUST THAT THE PROSTHESIS DOES NOT WORK. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD A MEDICAL APPOINTMENT SCHEDULED TO HAVE THE DOCTOR ASSESS HIM AND DECIDE WHEN THE SURGERY TO REMOVE THE PROSTHESIS IS GOING TO BE. THE PATIENT EXPERIENCED ERECTILE DYSFUNCTION DUE TO PROSTHESIS FAILURE SINCE APRIL 2019. ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER ALMOST 10 YEARS, THE INFLATABLE PENILE PROSTHESIS JUST STOPPED WORKING. THE UROLOGIST IS GOING TO REMOVE THE PROSTHESIS, HOWEVER, THERE IS NOT YET A SCHEDULED DATE FOR SURGERY. SINCE THE PROSTHESIS HAS NOT BEEN REMOVED FROM THE PATIENT YET, HE IS OK. IT IS JUST THAT THE PROSTHESIS DOES NOT WORK. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD A MEDICAL APPOINTMENT SCHEDULED TO HAVE THE DOCTOR ASSESS HIM AND DECIDE WHEN THE SURGERY TO REMOVE THE PROSTHESIS IS GOING TO BE. THE PATIENT EXPERIENCED ERECTILE DYSFUNCTION DUE TO PROSTHESIS FAILURE SINCE (B)(6) 2019. ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ALMOST 10 YEARS, THE INFLATABLE PENILE PROSTHESIS JUST STOPPED WORKING. THE UROLOGIST IS GOING TO REMOVE THE PROSTHESIS, HOWEVER, THERE IS NOT YET A SCHEDULED DATE FOR SURGERY. SINCE THE PROSTHESIS HAS NOT BEEN REMOVED FROM THE PATIENT YET, HE IS OK. IT IS JUST THAT THE PROSTHESIS DOES NOT WORK. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD A MEDICAL APPOINTMENT SCHEDULED TO HAVE THE DOCTOR ASSESS HIM AND DECIDE WHEN THE SURGERY TO REMOVE THE PROSTHESIS IS GOING TO BE. THE PATIENT EXPERIENCED ERECTILE DYSFUNCTION DUE TO PROSTHESIS FAILURE SINCE (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494088 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72403337 597718002

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R