BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 LGX

    MDR report key: 22948562 · Received September 2, 2025

    Report

    Report Number
    2124215-2025-61021
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    July 24, 2025
    Report Date
    November 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    UDI-DI
    00878953003955
    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) UNDERWENT A THOROUGH ANALYSIS. THE PUMP WAS MICROSCOPICALLY INSPECTED, FUNCTIONALLY AND LEAK TESTED. THE MICROSCOPE TEST REVEALED THAT THE PUMP KINK RESISTANT TUBING (KRT) WERE WORN TO THE FILAMENT. THE PUMP DID NOT PASS THE ACTIVATION TESTS. NO LEAKS WERE IDENTIFIED. THE CYLINDERS WERE MICROSCOPICALLY INSPECTED, AND LEAK TESTED. THE MICROSCOPE TEST REVEALED THAT THE FIRST CYLINDER HAD A LEAK AND A HOLE AT CORNER OF A FOLD IN THE PROXIMAL END OF THE CYLINDER. BOTH CYLINDERS HAD AD WEAR AT FOLD IN THE PROXIMAL END, MIDDLE, AND DISTAL END OF THE CYLINDER. THE SECOND CYLINDER HAD A HOLE AND LEAK IN THE PROXIMAL END OF THE CYLINDER FROM SHARP INSTRUMENT. THE RESERVOIR WAS MICROSCOPICALLY INSPECTED, AND LEAK TESTED. THE MICROSCOPE TEST FOUND THAT THE RESERVOIR HAD A WEAR AT A FOLD IN RESERVOIR SHELL. NO LEAKS WERE IDENTIFIED. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE HOLE/LEAK AT THE CORNER OF A FOLD IN THE FIRST CYLINDER AND THE PUMP NOT PASSING THE ACTIVATION TESTS CONFIRMED THE REPORTED CLINICAL OBSERVATION OF PUMP - 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) WENT TO THE HOSPITAL BECAUSE THE PRODUCT DID NOT WORK PROPERLY. TWO WEEKS LATER, AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THE CYLINDER HAD A HOLE, SO ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) WENT TO THE HOSPITAL BECAUSE THE PRODUCT DID NOT WORK PROPERLY. TWO WEEKS LATER, AS A RESULT OF THE INSPECTION, IT WAS CONFIRMED THAT THE CYLINDER HAD A HOLE, SO ALL COMPONENTS WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2332344 AMS 700 LGX PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 72404293 0179007001 00878953003955

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R UPN 72404161/ LOT 1000065900 RESERVOIR| UPN 72404161/ LOT 1000065900 RESERVOIR| UPN 72404310/ LOT 0184688009 PUMP| UPN 72404310/ LOT 0184688009 PUMP