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

Model Number	72404253-12
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this inflatable penile prosthesis (ipp) stopped inflating as intended.The patient suspects there is no fluid in the device, and it has lost its integrity.The patient was provided with troubleshooting instructions and is planning to consult with their physician.There has been no surgical intervention or patient complications reported.

• Brand Name: AMS 700 LGX MS 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: 20630289
• Report Number: 2124215-2024-69662
• Device Sequence Number: 8164172
• Product Code: JCW
• UDI-Device Identifier: 00878953009827
• UDI-Public: 00878953009827
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/12/2021
• Device Model Number: 72404253-12
• Device Catalogue Number: 72404253-12
• Device Lot Number: 1000369334
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/07/2024
• Date Device Manufactured: 12/13/2019
• 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: RESERVOIR: UPN 720185-01 / LOT 1000410617.
• Patient Age: 65 YR
• Patient Sex: Unknown