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

Model Number 72404156

Device Problem Malposition of Device (2616)

Patient Problems Arrhythmia (1721); Emotional Changes (1831); Micturition Urgency (1871); Muscle Weakness (1967); Neuropathy (1983); Pain (1994); Tachycardia (2095); Dysphasia (2195); Anxiety (2328); Discomfort (2330); Diaphoresis (2452); Cognitive Changes (2551); Movement Disorder (4412); Unspecified Mental, Emotional or Behavioural Problem (4430); Insufficient Information (4580)

Event Date 11/13/2023

Event Type  Injury  

Event Description

It was reported that, post-implant of this inflatable penile prosthesis, the patient experienced the following symptoms: it became uncomfortable to walk, the right foot was muscularly turned clockwise to the right; there was constant tension in the muscles of the right thigh and constant discomfort in all parts of the spine.There was discomfort when sitting, standing, and walking.The reservoir seemed to push the body back with its rigidity, this resolved when the reservoir was deflated and the implant was activated.There was also constant tension in the perineum in the proximal end of the implant.Implant activation caused an urge to go to the bathroom; upon deactivation, the urge subsided but the perineal tension remained.Night sweats, brain fog, periodic dysphasia, weakness, and a slight arrhythmia were also reported.Feelings of inhibition, lethargy, and low mood were also reported.The patient had anxiety and apathy related to the fact the procedure was not reversible.The patient body odor had become unpleasant and was noted to smell unnatural.The reservoir was removed and replaced on the left side in the space of retzius.No further patient complications were reported.

Manufacturer Narrative

Corrected data: h6 patient codes 9054: cognitive changes.

Event Description

It was reported that, post-implant of this inflatable penile prosthesis, the patient experienced the following symptoms: it became uncomfortable to walk, the right foot was muscularly turned clockwise to the right; there was constant tension in the muscles of the right thigh and constant discomfort in all parts of the spine.There was discomfort when sitting, standing, and walking.The reservoir seemed to push the body back with its rigidity, this resolved when the reservoir was deflated and the implant was activated.There was also constant tension in the perineum in the proximal end of the implant.Implant activation caused an urge to go to the bathroom; upon deactivation, the urge subsided but the perineal tension remained.Night sweats, brain fog, periodic dysphasia, weakness, and a slight arrhythmia were also reported.Feelings of inhibition, lethargy, and low mood were also reported.The patient had anxiety and apathy related to the fact the procedure was not reversible.The patient body odor had become unpleasant and was noted to smell unnatural.The reservoir was removed and replaced on the left side in the space of retzius.No further patient complications were reported.Further information received from the patient indicated that another third party physician advised the patient to remove the device due to potential autoimmune inflammation,.

Manufacturer Narrative

Corrected data: h6 patient codes 9054: cognitive changes.

Event Description

It was reported that, post-implant of this inflatable penile prosthesis, the patient experienced the following symptoms: it became uncomfortable to walk, the right foot was muscularly turned clockwise to the right; there was constant tension in the muscles of the right thigh and constant discomfort in all parts of the spine.There was discomfort when sitting, standing, and walking.The reservoir seemed to push the body back with its rigidity, this resolved when the reservoir was deflated and the implant was activated.There was also constant tension in the perineum in the proximal end of the implant.Implant activation caused an urge to go to the bathroom; upon deactivation, the urge subsided but the perineal tension remained.Night sweats, brain fog, periodic dysphasia, weakness, and a slight arrhythmia were also reported.Feelings of inhibition, lethargy, and low mood were also reported.The patient had anxiety and apathy related to the fact the procedure was not reversible.The patient body odor had become unpleasant and was noted to smell unnatural.The reservoir was removed and replaced on the left side in the space of retzius.No further patient complications were reported.Further information received from the patient indicated that another third party physician advised the patient to remove the device due to potential autoimmune inflammation.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: 18258680
• MDR Text Key: 329626695
• Report Number: 2124215-2023-68174
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003214
• UDI-Public: 00878953003214
• 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 Expiration Date: 04/13/2024
• Device Model Number: 72404156
• Device Catalogue Number: 72404156
• Device Lot Number: 1100117641
• 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: 04/14/2022
• 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