AMS 700 SPHERICAL RESERVOIR
Received Jun 23, 2026 · Event occurred May 1, 2026
Report 2124215-2026-33451 · MDR key 25602212
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404155Catalog number
72404155
Lot number
0160779016
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
83 YR · Male
- Discomfort
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED RESERVOIR DISCOMFORT. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE ENTIRE IPP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Additional Manufacturer Narrative
CORRECTION TO FIELD H11: ADDITIONAL MFR NARRATIVE 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. MODEL NUMBER/CATALOG NUMBER: 72404232. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0118882002. MODEL/CATALOG DESCRIPTION: CX PRECONNECT MS 18CM PS IZ. UNIQUE IDENTIFIER (UDI) #:(B)(4).
Additional Manufacturer Narrative
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. MODEL NUMBER/CATALOG NUMBER: 72404155. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0160779016. MODEL/CATALOG DESCRIPTION: RESERVOIR 65 ML PC/IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED RESERVOIR DISCOMFORT. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE ENTIRE IPP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.