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

Model Number	72404209
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during follow appointment, it was noted that the inflatable penile prosthesis (ipp) pump is not working properly, as the device is not having enough firmness in the cylinders and being points down when fully pumped.It was stated that this is causing pain in the glans on the right side, as well as an unspecified injury to the patient's wife.Additionally, it was noted that the patient had small skin dehiscence but is dry, with no signs of drainage or infection.The device remains implanted.

• 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: 18624881
• Report Number: 2124215-2024-01516
• Device Sequence Number: 17996295
• Product Code: FHW
• UDI-Device Identifier: 00878953003351
• UDI-Public: 00878953003351
• 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
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2024

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: 08/13/2022
• Device Model Number: 72404209
• Device Catalogue Number: 72404209
• Device Lot Number: 1000445332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• 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 UPN720185-01/LOT 1000407806.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Unknown