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

Device Problems Deflation Problem (1149); Mechanical Problem (1384); Difficult or Delayed Activation (2577)

Patient Problems Pain (1994); Urinary Retention (2119); Deformity/ Disfigurement (2360); Depression (2361); Fibrosis (3167); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 12/03/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced severe pain and swelling of his penis and testicles after a surgery to implant an inflatable penile prosthesis (ipp).During the time that the patient had the implant active, the ipp did not function.The patient could not sit for long periods of time because of pain.The patient also had pain with erections.The ipp caused the patient's penis to be in a semi-erect position and the patient was unable to deflate the ipp.The physician suspected a problem with the pump as it did not allow normal deactivation.The patient claims that the quality of his life has deteriorated due to the ipp malfunction and pain he has faced has affected his psychological state and he feels depressed, sad, upset, stressed, and angry.The patient's sleep has been disrupted and poor, and his sexual intimacy and relationship with his wife was affected.The patient took pain relief medications, including lyrica, but they did little to relieve his symptoms.The ipp was then removed, and the patient continued to experience penile and testicular pain and reports that his penis has been left disfigured and shrunk due to scarring.The patient is experiencing difficulties urinating and has pain, and sometimes urinary retention, when he attempts to empty his bladder.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12580721
• MDR Text Key: 274912434
• Report Number: 2124215-2021-29971
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): Y
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other; Required Intervention
• Patient Age: 60 YR