AMS 700 LGX
Received Jun 12, 2025 · Event occurred May 8, 2025
Report 2124215-2025-38601 · MDR key 22196355
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404293Catalog number
72404293
Lot number
825031002
Product problems
- Mechanical Problem
- Material Puncture/Hole
- Mechanical Problem
- Material Puncture/Hole
Patient
71 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CONCOMITANT PRODUCT UDI FOR PUMP IS (B)(4). CONCOMITANT PRODUCT UDI FOR RESERVOIR IS (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC BECAUSE THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT WORKING PROPERLY. TWO WEEKS LATER, A SURGICAL PROCEDURE WAS PERFORMED, DURING WHICH A CRACK IN THE LEFT CYLINDER CONNECTING TUBE WAS IDENTIFIED. THE CAUSE OF THE CRACK IN THE CONNECTING TUBE WAS NOT DETAILED BY THE HOSPITAL. THE PUMP WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.