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

Model Number UNK-P-IPP

Device Problems Deflation Problem (1149); Inflation Problem (1310)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/30/2019

Event Type  malfunction  

Event Description

It was reported that the patient has experienced mechanical issues with a ten year old inflatable penile prosthesis (ipp) during the past couple of years.The patient stated having difficulty inflating and deflating the device as it required more pumps and significant pressure to inflate, however the patient was still able to use the device.The patient also noticed gradual decreased sensitivity along the penile shaft.During an appointment with the physician they were able to operate the ipp but the need for more pressure was confirmed.The physician also indicated that there was no treatment for the reduced sensation and it appears to be related to older age.The physician would provide the required details needed to decide whether the patient wanted to undergo a replacement procedure.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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 ; 4083953452
• MDR Report Key: 9618125
• MDR Text Key: 175929250
• Report Number: 2183959-2020-00195
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK-P-IPP
• Device Catalogue Number: UNK-P-IPP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 79 YR