BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEAL

    MDR report key: 24690018 · Received March 25, 2026

    Report

    Report Number
    2124215-2026-16374
    Event Type
    Injury
    Date Received
    March 25, 2026
    Date of Event
    November 1, 2025
    Report Date
    March 25, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    UDI-DI
    00878953005676
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER: 72404308. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000591406. MODEL/CATALOG DESCRIPTION: LGX PRECONNECT MS 21CM IP. UNIQUE IDENTIFIER (UDI) # (B)(6). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, THE CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED PAIN NEAR HIS IMPLANT. IT WAS NOTED THAT THE RESERVOIR HAD MIGRATED OUT OF THE ORIGINAL POCKET AND DOWN INTO THE GROIN AREA. THE SURGEON BELIEVES THAT WHERE THE RESERVOIR IS NOW LOCATED IS PRESSING ON A NERVE AND CAUSING THE PAIN. THE PATIENT INFLATES THE DEVICE TO REDUCE THE PRESSURE ON THE NERVE TO REDUCE THE PAIN. IT WAS NOTED THAT THIS DEVICE DOES NOT FULLY DEFLATE AND THE RESERVOIR IS POSSIBLY FOLDED, THEREFORE, A RESERVOIR REPLACEMENT SURGERY WAS SUGGESTED. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752616 CONCEAL PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 72018201 1100197635 00878953005676

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention| H| O