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

Model Number	72404250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	08/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented at the four week follow up with a hole in their scrotum, under the pump.The physician tested for infection and confirmed abnormal findings.The patient was placed on antibiotics for two weeks, and then performed a wash out and replaced the pump.Another swab for infection was performed and returned as normal.There were no additional patient complications reported.
Additional Manufacturer Narrative
D6b explant date is an estimate.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) presented at the four week follow up with erosion of the pump and a hole in their scrotum.The physician tested for infection and confirmed abnormal findings.The patient was placed on antibiotics for two weeks, and then performed a wash out and replaced the pump.Another swab for infection was performed and returned as normal.There were no additional patient complications reported.
Additional Manufacturer Narrative
Updated information to b5 describe event/problem, b3 date of event, and h6 patient codes.Correction made to d6b explant date.The explant date is an estimate.

• 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: 20599079
• Report Number: 2124215-2024-68985
• Device Sequence Number: 8787910
• Product Code: FHW
• UDI-Device Identifier: 00878953003580
• UDI-Public: 00878953003580
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/12/2025
• Device Model Number: 72404250
• Device Catalogue Number: 72404250
• Device Lot Number: 1100315199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/05/2024
• Date Device Manufactured: 06/13/2023
• 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#: 1100505116; RESERVOIR UPN: 72404155 LOT#: 1100505116
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Unknown