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

Model Number 720185-01

Device Problem Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported that due to a bulge in the patient's lower abdomen the patient had his inflatable penile prosthesis (ipp) removed and replaced.The physician determined that the reservoir had migrated and the patient did not experience any issues with his device and his device was functioning.The patient first visited his physician at the end of (b)(6) 2019.During this surgery the physician made another pocket and reinserted the reservoir.The fascia was closed over.There were no known patient issues as a result of this surgery.

Manufacturer Narrative

B5: update to event description h3 other text : device not returned for evaluation.

Event Description

It was reported that due to a bulge in the patient's lower abdomen the patient had his inflatable penile prosthesis (ipp) removed and replaced.The physician determined that the reservoir had migrated and the patient did not experience any issues with his device and his device was functioning.The patient first visited his physician at the end of october 2019.During this surgery the physician made another pocket and reinserted the reservoir.The fascia was closed over.There were no known patient issues as a result of this surgery.It was further reported that the reservoir was originally placed in the prevesical space and migrated right under the fascia.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9587670
• MDR Text Key: 174928358
• Report Number: 2183959-2020-00084
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953005669
• UDI-Public: 00878953005669
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/09/2021
• Device Model Number: 720185-01
• Device Catalogue Number: 720185-01
• Device Lot Number: 1000270880
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Patient Sequence Number: 1
• Treatment: 1000217541; 1000217541; 1000217541
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR