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

Model Number	72404173
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	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Neither the reported patient symptoms or device performance allegation can be confirmed.Based on the information available, a conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to remove this inflatable penile prosthesis (ipp) due to scrotal infection and erosion; it was noted the pump could be visualized outside the scrotum.The ipp was explanted and replaced with a tactra malleable prosthesis.The patient fully recovered.

• 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
• MDR Report Key: 12600641
• Report Number: 2124215-2021-30371
• Device Sequence Number: 4522481
• Product Code: FHW
• UDI-Device Identifier: 00878953003276
• UDI-Public: 00878953003276
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/08/2021

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: 12/08/2022
• Device Model Number: 72404173
• Device Catalogue Number: 72404173
• Device Lot Number: 1000500208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 48 YR