BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 10393189 · Received August 11, 2020

    Report

    Report Number
    2183959-2020-03478
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 18, 2020
    Report Date
    September 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953003986
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AN ALLEGATION OF A TUBING CRACK AND FLUID LOSS WAS REPORTED. THE AMS700 MS PUMP WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. THE PUMP WAS FUNCTIONALLY TESTED AND FAILED ACTIVATION TEST, REQUIRING MORE THAN 8LBS. OF FORCE TO ACTIVATE. PRODUCT ANALYSIS CONFIRMED A DEVICE MALFUNCTION WITH THE PUMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE DEVICE NOT WORKING PROPERLY AND NOT ACTIVATING DUE TO A SALINE LEAK 2 WEEKS PRIOR TO THE REVISION PROCEDURE WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP PUP WAS EXPLANTED AND A NEW IPP PUMP WAS IMPLANTED. DURING THE REVISION PROCEDURE THE PUMP CONNECTION TUBE WAS CRACKED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO THE DEVICE NOT WORKING PROPERLY AND NOT ACTIVATING DUE TO A SALINE LEAK 2 WEEKS PRIOR TO THE REVISION PROCEDURE WITH AN INFLATABLE PENILE PROSTHESIS (IPP). THE IPP PUP WAS EXPLANTED AND A NEW IPP PUMP WAS IMPLANTED. DURING THE REVISION PROCEDURE THE PUMP CONNECTION TUBE WAS CRACKED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857019 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404310 0175687007 00878953003986

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization