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

Model Number 72404232-10

Device Problem Defective Device (2588)

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

Event Date 01/06/2020

Event Type  malfunction  

Event Description

It was reported that the patient experienced a malfunctioning inflatable penile prosthesis(ipp) pump.The pump is as hard as a rock, and the patient is concerned that the physician wants to replace the pump.Additional information received that the doctor is going ahead with the valve replacement.The patient reported that the deflate button slowly retracted when trying techniques that the liaison suggested upon his reported malfunctioning device.

Manufacturer Narrative

Additional information received that the revision surgery was scheduled for (b)(6) 2020 and was cancelled by the patient because the patient began to be able to pump up the device.

Event Description

It was reported that the patient experienced a malfunctioning inflatable penile prosthesis(ipp) pump.The pump is as hard as a rock, and the patient is concerned that the physician wants to replace the pump.Additional information received that the doctor is going ahead with the valve replacement.The patient reported that the deflate button slowly retracted when trying techniques that the liaison suggested upon his reported malfunctioning device.

• 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: 9647912
• MDR Text Key: 177021145
• Report Number: 2183959-2020-00350
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2021
• Device Model Number: 72404232-10
• Device Catalogue Number: 72404232-10
• Device Lot Number: 1000291375
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/10/2020
• Patient Sequence Number: 1
• Patient Age: 79 YR