BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8841550 · Received July 30, 2019

    Report

    Report Number
    2183959-2019-65367
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    July 11, 2019
    Report Date
    October 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953002705
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS: PATIENT DISSATISFACTION WAS REPORTED. THE AMS700 DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. NO LEAK WAS FOUND. THE CYLINDERS PERFORMED WITHIN SPECIFICATIONS. NO DEVICE MALFUNCTION OR ISSUE WAS 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. PUMP ANALYSIS: PATIENT DISSATISFACTION WAS REPORTED. THE AMS700 MOMENTARY SQUEEZE PUMP WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. NO LEAK WAS FOUND. THE PUMP FAILED THE 8 LB. ACTIVATION TEST. THE PUMP REQUIRED MORE THAN 8 LBS. OF FORCE TO ACTIVATE. THE PUMP FAILED THE INFLATION TEST AND DID NOT TRANSFER A SUFFICIENT AMOUNT OF FLUID TO FULLY INFLATE THE CYLINDERS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE PENIS BENDING FORWARD WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP CYLINDER AND PUMP WERE EXPLANTED AND A NEW IPP CYLINDER AND PUMP WERE IMPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS. ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT HAD PAIN IN THE PENIS AND THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE PENIS BENDING FORWARD WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP CYLINDER AND PUMP WERE EXPLANTED AND A NEW IPP CYLINDER AND PUMP WERE IMPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS. ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT HAD PAIN IN THE PENIS AND THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE PENIS BENDING FORWARD WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP CYLINDER AND PUMP WERE EXPLANTED AND A NEW IPP CYLINDER AND PUMP WERE IMPLANTED. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE OR THE PRODUCT WAS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636066 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404013 0188517007 00878953002705

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R