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

Model Number 720185-01

Device Problem Malposition of Device (2616)

Patient Problems Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Tachycardia (2095); Dysphasia (2195); Discomfort (2330); Diaphoresis (2452); 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 2124215-2023-68222) it was reported that following a revision of this inflatable penile prosthesis reservoir, the following persistent symptoms continued to interfere with life: sweating, weakness, apathy, brain fog.The patient was unable to use the device as often as liked due to lack of energy, constant brain fog, and the other symptoms.The patient had a decrease in communication with people, work, pleasure from life, good mood.The patient had difficulty in ordinary everyday activities as well as an increase in sleeping that did not provide for good recovery and energy.The patient was expected to have a malleable penile prosthesis implanted.No further patient complications were reported.

Manufacturer Narrative

Corrected data: h6 patient codes dysphasia e0113 removed.

Event Description

(refer to manufacturer report 2124215-2023-68222) it was reported that following a revision of this inflatable penile prosthesis reservoir, the following persistent symptoms continued to interfere with life: sweating, weakness, apathy, brain fog.The patient was unable to use the device as often as liked due to lack of energy, constant brain fog, and the other symptoms.The patient had a decrease in communication with people, work, pleasure from life, good mood.The patient had difficulty in ordinary everyday activities as well as an increase in sleeping that did not provide for good recovery and energy.The patient was expected to have a malleable penile prosthesis implanted.No further patient complications were reported.

Manufacturer Narrative

Corrected data: h6 patient codes dysphasia, e0113 removed.

Event Description

Refer to manufacturer report 2124215-2023-68222 it was reported that following a revision of this inflatable penile prosthesis reservoir, the following persistent symptoms continued to interfere with life: sweating, weakness, apathy, brain fog.The patient was unable to use the device as often as liked due to lack of energy, constant brain fog, and the other symptoms.The patient had a decrease in communication with people, work, pleasure from life, good mood.The patient had difficulty in ordinary everyday activities as well as an increase in sleeping that did not provide for good recovery and energy.The patient was expected to have a malleable penile prosthesis implanted.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 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: 18259536
• MDR Text Key: 329668141
• Report Number: 2124215-2023-68226
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005669
• UDI-Public: 00878953005669
• Combination Product (y/n): Y
• 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,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: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1100235278
• 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: 12/20/2022
• 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): Required Intervention; Hospitalization