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

Catalog Number 72404232

Device Problems Inflation Problem (1310); Mechanical Problem (1384); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 10/25/2018

Event Type  Injury  

Manufacturer Narrative

Updated event description and coding.

Event Description

It was reported that the patient's inflatable penile prosthesis only worked three-quarters of the way.The patient met with "a rep at the office" who stated that the device may be defective.This complaint was initially submitted to fda via asr report q3 2018 and additional information was received by boston scientific.Due to the removal of exemption e1997037, this information is provided via supplemental report.Additional information received indicated the patient had his inflatable penile prosthesis cx model 18 cm cylinders and pump removed as the device was not fully inflating as it had crossed over at the time of the last surgery.A new inflatable penile prosthesis cx model 21 cm cylinders and ms pump were implanted.The patient experienced no other symptoms.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Type of Device: DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 8024009
• MDR Text Key: 125648302
• Report Number: 2183959-2018-00113
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003450
• UDI-Public: 00878953003450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2020
• Device Catalogue Number: 72404232
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR