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

Model Number 72402987

Device Problem Failure to Cycle (1142)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision procedure due to the device stopped cycling with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.The patient was fine following the procedure.

Event Description

It was reported that the patient underwent a revision procedure due to the device stopped cycling with an inflatable penile prosthesis (ipp).The ipp cylinder, pump, and reservoir was explanted and a new ipp cylinder, pump, and reservoir was implanted.The patient was fine following the procedure.

• 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: 10652743
• MDR Text Key: 210570773
• Report Number: 2183959-2020-04542
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• PMA/PMN Number: N970012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/2006
• Device Model Number: 72402987
• Device Catalogue Number: 72402987
• Device Lot Number: 390823002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/15/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR