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

Model Number	72404255
Medical Device Problem Codes	Inflation Problem (1310); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event entered is an estimated date as the exact date of event was not provided.
Event or Problem Description
It was reported that the inflatable penile prosthesis (ipp) device is going to be revised on a future date because over the last three months the patient has observed a "progressive loss of penile stiffness and difficulty handling the pump and inflating the cylinders." "physical urological examination shows well-located system components and without phlogistic signs or external deformations with failure in the filling system when starting the pump." as a result of the examination the surgeon as decided to do a surgical exploration of the device system.If necessary, the device will be replaced.

• 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: 10496650
• Report Number: 2183959-2020-03949
• Device Sequence Number: 11485390
• Product Code: FHW
• UDI-Device Identifier: 00878953003634
• UDI-Public: 00878953003634
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/18/2021
• Device Model Number: 72404255
• Device Catalogue Number: 72404255
• Device Lot Number: 1000263950
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/04/2020
• Patient Sequence Number: 1
• Patient Age: 83 YR