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

Model Number 72404252-10

Device Problems Use of Device Problem (1670); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 08/03/2020

Event Type  Injury  

Event Description

It was reported that the initial lgx 18 ps cylinders were implanted in (b)(6) 2020.The patient recovered well but when it came to using the device, was unable to reach his pump due to the positioning in his scrotum.Patient experienced pain.The physician requested a revision surgery.Instead of utilizing the initial implant, the physician requested a new pump with additional tubing length to ensure the pump would be in a better more anterior spot in the patients scrotum.A new pump from a cxr cylinder was implanted in the scrotum.The patient is expected to do well.This was not a device issue, but instead a placement issue for the patient to use the device.

• 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 west; minnetonka MN 55343
• Manufacturer Contact: alyson harris ; 10700 bren road w; minnetonka, MN 55343 ; 4089353452
• MDR Report Key: 10440655
• MDR Text Key: 203988212
• Report Number: 2183959-2020-03671
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2021
• Device Model Number: 72404252-10
• Device Catalogue Number: 72404252-10
• Device Lot Number: 1000363325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR