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

Model Number 72404252-10

Device Problems Collapse (1099); Failure to Cycle (1142); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2020

Event Type  Injury  

Event Description

It was reported that the patient indicated that recently when the pump of the inflatable penile prosthesis (ipp) was squeezed, it went and stayed flat.Patient was able to realize the "pop" but after that the pump would not refill.Patient liaison provided trouble shooting and rebooting maneuvers which the patient would try.The patient would contact a physician for follow up and assessment if the maneuvers were not successful.No more information available at the moment.Should additional information become available, it will be provided.

Event Description

It was reported that the patient indicated that recently when the pump of the inflatable penile prosthesis (ipp) was squeezed, it stayed flat.Patient was able to realize the "pop" but after that the pump would not refill.Patient liaison provided trouble shooting and rebooting maneuvers which the patient would try.The patient would contact a physician for follow up and assessment if the maneuvers were not successful.Three months later, a surgical procedure was performed in which the pump was removed and replaced.During the procedure the tubing was found to be kinked.No information was provided about the patient's outcome.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10197864
• MDR Text Key: 197128982
• Report Number: 2183959-2020-02701
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009810
• UDI-Public: 00878953009810
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2022
• Device Model Number: 72404252-10
• Device Catalogue Number: 72404252-10
• Device Lot Number: 1000379186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR