MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE; DEVICE IMPOTENCE MECHANICAL/HYDRAULIC

Model Number	72404236
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) is unable to use the pump.During the original implant, the cylinders and pump were working properly.Post procedure, the medical specialist made multiple attempts to activate the pump and was unsuccessful.A revision procedure was scheduled to change out the ipp.There has been no surgical intervention at this time, and there were no patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) is unable to use the pump.During the original implant, the cylinders and pump were working properly.Post procedure, the medical specialist made multiple attempts to activate the pump and was unsuccessful.A revision procedure was scheduled to change out the ipp.There has been no surgical intervention at this time, and there were no additional patient complications reported.
Additional Manufacturer Narrative
Correction to e1 initial reported address.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• 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: 19260796
• Report Number: 2124215-2024-27618
• Device Sequence Number: 2686037
• Product Code: FHW
• UDI-Device Identifier: 00878953003498
• UDI-Public: 00878953003498
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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: 01/24/2025
• Device Model Number: 72404236
• Device Catalogue Number: 72404236
• Device Lot Number: 1100248723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• 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: 72404155 LOT#: 1100310413; RESERVOIR: UPN: 72404155 LOT#: 1100310413
• Patient Age: 63 YR
• Patient Sex: Male