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

Model Number	72404156
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Codes	Hernia (2240); Unspecified Tissue Injury (4559)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) had the reservoir replaced due to it herniating.There were no patient complications reported.
Event or Problem Description
It was reported that the patient with this inflatable penile prosthesis (ipp) had the reservoir replaced due to it herniating.There were no patient complications reported.
Additional Manufacturer Narrative
Correction to field h6: patient code.Correction to field h6: device code.

• 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: 19982640
• Report Number: 2124215-2024-50477
• Device Sequence Number: 19517121
• Product Code: FHW
• UDI-Device Identifier: 00878953003214
• UDI-Public: 00878953003214
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2024

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: 07/25/2025
• Device Model Number: 72404156
• Device Catalogue Number: 72404156
• Device Lot Number: 1100335055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 08/22/2024
• Date Device Manufactured: 07/26/2023
• 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: 72404156 LOT #: 1100335055; RESERVOIR, UPN: 72404156 LOT #: 1100335055
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown