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

Model Number	72404287
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced infection with an inflatable penile prosthesis (ipp).It was indicated that the infection was located in the scrotum and followed the tubing.The physician believed the device contributed to the infection but the onset of the symptoms was unknown.A surgical procedure was performed in which the existing ipp was removed and a new tactra penile prosthesis was implanted.There were no device malfunctions associated with the explanted device and the patient did not experience further complications.The post-operational antibiotic treatment information was unavailable.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11328115
• Report Number: 2183959-2021-00428
• Device Sequence Number: 11428130
• Product Code: FHW
• UDI-Device Identifier: 00878953003900
• UDI-Public: 00878953003900
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/15/2021

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: 10/21/2024
• Device Model Number: 72404287
• Device Catalogue Number: 72404287
• Device Lot Number: 1000346978
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/15/2021
• 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: 70 YR