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

Model Number	72404230
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has been experiencing problems with this inflatable penile prosthesis (ipp) as it has not been inflating.A revision surgery will be performed in the future.
Additional Manufacturer Narrative
The following field have been updated: b1: adverse event/product problem, b2: outcomes attrib to adv event, b5: describe event or problem, d6b: explant date, h1: type of reportable event, h6: impact and device codes.
Event or Problem Description
It was reported that the patient has been experiencing problems with this inflatable penile prosthesis (ipp) as it has not been inflating and deflating properly.A surgical procedure was performed and all components were removed and replaced.There were no patient complications reported.

• 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: 16728876
• Report Number: 2124215-2023-17199
• Device Sequence Number: 17824248
• Product Code: FHW
• UDI-Device Identifier: 00878953003436
• UDI-Public: 00878953003436
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/16/2017
• Device Model Number: 72404230
• Device Catalogue Number: 72404230
• Device Lot Number: 102010003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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: 720185-01LOT: 931912011; RESERVOIR:UPN: 720185-01LOT: 931912011
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male