BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 LGX

    MDR report key: 23127809 · Received September 23, 2025

    Report

    Report Number
    2124215-2025-66712
    Event Type
    Injury
    Date Received
    September 23, 2025
    Date of Event
    August 14, 2025
    Report Date
    December 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    UDI-DI
    00878953003955
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4) AND FOR RESERVOIR IS (B)(4). G4: PMA/510(K) # FIELD ON 3500A FORM IS N970012, P000053 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS INFLATABLE PENILE PROSTHESIS (IPP) CYLINDER AND PUMP UNDERWENT A THOROUGH ANALYSIS. THE PUMP WAS MICROSCOPICALLY INSPECTED, FUNCTIONALLY AND LEAK TESTED. UNDER MICROSCOPE OBSERVATION, CONTAMINATION (BODILY FLUID) WAS FOUND WITHIN THE MS PUMP. AS A RESULT, THE FUNCTIONAL TEST WAS NOT PERFORMED. THE PUMP TUBING WAS CUT DOWN TO THE PUMP BLOCK; THE TUBING WAS RETURNED ATTACHED TO THE CYLINDERS. NO LEAKS WERE IDENTIFIED. THE CYLINDER WAS MICROSCOPICALLY INSPECTED, AND LEAK TESTED. THE MICROSCOPE TEST FOUND THAT THE CYLINDER HAD AT CORNER OF A FOLD IN THE PROXIMAL END OF THE CYLINDER AND HAD WEAR AT FOLD IN THE PROXIMAL END AND DISTAL END OF THE CYLINDER. THE CYLINDER DID NOT PASS THE LEAK TEST. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE HOLE/LEAK AT THE CORNER OF A FOLD IN THE FIRST CYLINDER CONFIRMED THE REPORTED CLINICAL OBSERVATION OF DEVICE- MECHANICAL ISSUE AND CYLINDER - HOLE/PERFORATED.

    Additional Manufacturer Narrative · 0

    D4. CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4) AND FOR RESERVOIR IS (B)(4). G4: PMA/510(K) # FIELD ON 3500A FORM IS N970012, P000053 - REPORTED HERE AS PMA # EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) VISITED THE HOSPITAL BECAUSE THE PRODUCT DID NOT FUNCTION PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE LEFT CYLINDER HAD A HOLE, SO THE LEFT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) VISITED THE HOSPITAL BECAUSE THE PRODUCT DID NOT FUNCTION PROPERLY. TWO WEEKS LATER UPON INSPECTION, IT WAS CONFIRMED THAT THE LEFT CYLINDER HAD A HOLE, SO THE LEFT CYLINDER AND THE PUMP WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540995 AMS 700 LGX PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 72404293 0135694004 00878953003955

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R UPN: 7240182-01 LOT: 128306006 - RESERVOIR.| UPN: 72404310 LOT: 149291005 - PUMP.