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

Model Number 720182-01

Device Problem Malposition of Device (2616)

Patient Problems Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Tachycardia (2095); Discomfort (2330); Diaphoresis (2452); Balance Problems (4401); Unspecified Mental, Emotional or Behavioural Problem (4430); Insufficient Information (4580)

Event Date 11/13/2023

Event Type  Injury  

Event Description

(refer to manufacturer report ref (b)(4) ) it was reported that, following replacement and repositioning of the inflatable penile prosthesis reservoir ectopically in the iliac region, the patient was more comfortable standing and the leg and gait issues experienced following the previous implant resolved.However, it was noted that balance did not fully return.When walking and sitting, it felt that the reservoir was interfering with the body rigidity, as if pushing it back.Upon device activation, the rigidity subsided and tension in the perineum increased.The new position of the reservoir was more comfortable but persistent symptoms, including night sweats, weakness, apathy, and brain fog remained, impacting quality of life.No further patient complications were reported.

Event Description

(refer to manufacturers report ref# (b)(4)) it was reported that, following replacement and repositioning of the inflatable penile prosthesis reservoir ectopically in the iliac region, the patient was more comfortable standing and the leg and gait issues experienced following the previous implant resolved.However, it was noted that balance did not fully return.When walking and sitting, it felt that the reservoir was interfering with the body rigidity, as if pushing it back.Upon device activation, the rigidity subsided and tension in the perineum increased.The new position of the reservoir was more comfortable but persistent symptoms, including night sweats, weakness, apathy, and brain fog remained, impacting quality of life.No further patient complications were reported.Further information received indicated the patient experienced signs of ongoing moderate autoimmune symptoms as well as tachycardia, weakness, lethargy, hypertonicity in the leg, lower back pain, and scoliosis.A neurologist treated the patient for pain without any effect.There were polymorphic neurological symptoms associated with the reservoir in the retzius space.The patient symptoms were presumed by the physician to be related to obturator nerve syndrome due to the reservoir placement.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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: 18259715
• MDR Text Key: 329633289
• Report Number: 2124215-2023-68222
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005676
• UDI-Public: 00878953005676
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 720182-01
• Device Catalogue Number: 720182-01
• Device Lot Number: 1100165967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention