AMS 700 CXR
Received Jun 22, 2026 · Event occurred May 29, 2026
Report 2124215-2026-33244 · MDR key 25588548
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404013Catalog number
72404013
Lot number
0179150006
Product problems
- Fluid/Blood Leak
- Inflation Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE REPEATEDLY PRESSING THE CONTROL SWITCH ON THE PUMP OF THE INFLATABLE PENILE PROSTHESIS (IPP) IT WOULD REBOUND NORMALLY BUT THE CYLINDER HAD NO RESPONSE AND WOULD NOT INFLATE NORMALLY. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT THE PHYSICIAN NOTICED WATER WAS REDUCED IN THE RESERVOIR. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Additional Manufacturer Narrative
MODEL NUMBER/CATALOG NUMBER: 720182-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0178273001. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT 100 ML. UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: 72404310. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 0176309003. MODEL/CATALOG DESCRIPTION: PUMP MS. UNIQUE IDENTIFIER (UDI) #: (B)(4).