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

Model Number 72404252-10

Device Problems Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384); Defective Device (2588); Material Deformation (2976)

Patient Problems Capsular Contracture (1761); Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 11/01/2020

Event Type  Injury  

Manufacturer Narrative

The exact event date is unknown.As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint, the reported allegation could not be confirmed.The event cannot be reproduced or substantiated.

Event Description

It was reported that the patient had his inflatable penile prosthesis (ipp) implanted on (b)(6) 2020 and after some post operation sessions with his doctor and a company representative he has experienced persistent difficulties.The difficulties consist of a very arduous time squeezing the pump bulb through strong resistance (it fights back), only to achieve a semi-rigid erection, at about roughly an 80% angle.There is a lot of internal fibrous tissue surrounding the bulb and the deflation button, which makes it very hard to actuate them.After several painful and difficult squeezes, the erection arrives, but it is certainly not of the expected quality.The deflation button is even more difficult because of interfering fibrous tissue makes it difficult to localize, and the squeezing necessary to achieve deflation is very hard to do and can be quite painful.He typically achieves little to no deflation, and has to wait over a period of days for any meaningful deflation to occur over time.The patient indicates that he has taken oxycodones to be able to stand the pain when trying to use the deflation button, therefore, the patient has given up on any further usage of the device.The patient and his wife dislike that the penis has shortened significantly.The patient indicated that the doctor had to place the reservoir very low in his abdomen because excessive scarring from a previous abdominoplasty prevented placing it higher.The patient wonders if any of his difficulties could stem from long tubes with a short run, possibly creating kinks.The patient will continue follow up with his doctor.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 11003860
• MDR Text Key: 221452402
• Report Number: 2183959-2020-05878
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009810
• UDI-Public: 00878953009810
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Model Number: 72404252-10
• Device Catalogue Number: 72404252-10
• Device Lot Number: 1000452239
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR