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

Model Number 72404233-12

Device Problem Inflation Problem (1310)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 12/08/2023

Event Type  Injury  

Event Description

It was reported that the patient with an inflatable penile prosthesis (ipp) experienced difficulty with inflating the device and obtaining an erection.The patient reported feeling pain, burning, and a lightening sensation in the penis.The physician advised the patient to continue to cycle and practice with the device and the pain should subside.There was no pump training or inflation of the device at the consult with the physician.A follow-up appointment was scheduled four months later; however, the patient will attempt to schedule a sooner appointment to determine if there is a device malfunction.

Manufacturer Narrative

There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that the patient with an inflatable penile prosthesis (ipp) experienced difficulty with inflating the device and obtaining an erection.The patient reported feeling pain, burning, and a lightening sensation in the penis.The physician advised the patient to continue to cycle and practice with the device and the pain should subside.There was no pump training or inflation of the device at the consult with the physician.A follow-up appointment was scheduled four months later; however, the patient will attempt to schedule a sooner appointment to determine if there is a device malfunction.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18357666
• MDR Text Key: 330898282
• Report Number: 2124215-2023-72103
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953009797
• UDI-Public: 00878953009797
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 72404233-12
• Device Catalogue Number: 72404233-12
• Device Lot Number: 1100339654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RESERVOIR UPN: 720185-01 LOT#: 1100339733; RESERVOIR UPN: 720185-01 LOT#: 1100339733
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male