MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 700 LGX TENACIO PUMP; PROSTHESIS, PENIS, INFLATABLE

Model Number	72404456
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was auto inflating.The ipp was explanted.There were no patient complications reported.
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) was auto inflating.The ipp was explanted.There were no patient complications reported.
Additional Manufacturer Narrative
Updated evaluation conclusion codes h6.Upon receipt at our quality assurance laboratory, the pump of this device underwent a thorough analysis.The pump was microscopically examined, and leak and functionally tested.No anomalies were found with the pump.Based on the information available and analysis results, the reported clinical observation of spontaneous deflation could not be confirmed.

• Brand Name: AMS 700 LGX TENACIO PUMP
• Common Device Name: PROSTHESIS, PENIS, INFLATABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 21123713
• Report Number: 2124215-2024-83565
• Device Sequence Number: 20698841
• Product Code: JCW
• UDI-Device Identifier: 00191506021467
• UDI-Public: 00191506021467
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/15/2026
• Device Model Number: 72404456
• Device Catalogue Number: 72404456
• Device Lot Number: 1100547777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LGX PRECONNECT: LOT 1100547777 UPN 72404456; LGX PRECONNECT: LOT 1100547777 UPN 72404456
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Unknown