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

Model Number	72404266
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent an inflatable penile prosthesis (ipp) revision surgery due to an unspecified malfunction.The existing cylinders and pump components were explanted and replaced with new components.The existing reservoir remains implanted in the patient.The explanted components are not expected to be returned.Should additional information be received, or product be returned, a supplemental report will be filed upon completion of the product analysis.
Event or Problem Description
It was reported the patient underwent an inflatable penile prosthesis (ipp) revision surgery due to an unspecified malfunction.The existing cylinders and pump components were explanted and replaced with new components.The existing reservoir remains implanted in the patient.The explanted components are not expected to be returned.Should additional information be received, or product be returned, a supplemental report will be filed upon completion of the product analysis.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8505578
• Report Number: 2183959-2019-62178
• Device Sequence Number: 198086
• Product Code: FHW
• UDI-Device Identifier: 00878953003740
• UDI-Public: 00878953003740
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019

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: 03/12/2016
• Device Model Number: 72404266
• Device Catalogue Number: 72404266
• Device Lot Number: 873396002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR