AMS 700 LGX TENACIO PUMP
Received Feb 11, 2025 · Event occurred Nov 4, 2024
Report 2124215-2025-07234 · MDR key 21355867
Device
Generic name
Prosthesis, Penis, Inflatable
Manufacturer
Boston Scientific CorporationModel number
72404453Catalog number
72404453
Lot number
1100523972
Product problems
- Migration
- Migration
Patient
74 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION UPDATED: A2: AGE. A3A: SEX. A3B: GENDER. B1: ADVERSE EVENT/PRODUCT PROBLEM. B2: OUTCOMES ATTRIB TO ADV EVENT. B3: DATE OF EVENT. B5: DESCRIBE EVENT/PROBLEM. B7: OTHER RELEVANT HISTORY. D4: MODEL NUMBER, LOT NUMBER, CATALOG NUMBER, EXPIRATION DATE, UNIQUE IDENTIFIER. C2/D10: CONCOMITANT PRODUCT/THERAPY. H1: TYPE OF REPORTABLE EVENT. H6: IMPACT CODES.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH THE PUMP RIDING HIGH IN THE SCROTUM, MAKING THE COMPONENT DIFFICULT TO OPERATE; THEREFORE, A REVISION SURGERY WAS PERFORMED TO REMOVE THE TENACIO PUMP AND REPLACE IT WITH A MS PUMP. THE PHYSICIAN STATED THE MIGRATION MAY BE DUE TO THE NEW LOCATION OF THE RESERVOIR TUBING CONNECTING TO THE TENACIO PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH THE PUMP RIDING HIGH IN THE SCROTUM, MAKING THE COMPONENT DIFFICULT TO OPERATE; THEREFORE, A REVISION SURGERY WAS PERFORMED TO REMOVE THE TENACIO PUMP AND REPLACE IT WITH A MS PUMP. THE PHYSICIAN STATED THE MIGRATION MAY BE DUE TO THE NEW LOCATION OF THE RESERVOIR TUBING CONNECTING TO THE TENACIO PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THIS EVENT WAS PREVIOUSLY REPORTED. SEE MFR. REPORT #2124215-2024-78313. FURTHER INFORMATION WILL BE UPDATED WITH REPORT #2124215-2024-78313.
Additional Manufacturer Narrative
THE EXACT EVENT DATE WAS NOT AVAILABLE, THEREFORE THE DATE 12/01/2024 WAS USED AS ESTIMATE, AS IT WAS REPORTED THAT THE EVENT OCCURRED IN DECEMBER.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH THE PUMP RIDING HIGH IN THE SCROTUM. PHYSICIAN STATED IT MAY BE DUE TO THE NEW LOCATION OF THE RESERVOIR TUBING CONNECTING TO THE TENACIO PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED.