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

Model Number 72404253

Device Problem Defective Device (2588)

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

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event entered is an estimated date as the exact date of event was not provided.

Event Description

It was reported that the patient is not able to depress the pump of his inflatable penile prosthesis (ipp) device because it is "hard as a rock." the patient was provided with troubleshooting techniques to try in order to get the pump to depress.He stated he will contact bsc again if he has any further questions.

Manufacturer Narrative

Additional manufacturer narrative: b3 - date of event entered is an estimated date as the exact date of event was not provided.

Event Description

It was reported that the patient is not able to depress the pump of his inflatable penile prosthesis (ipp) device because it is "hard as a rock." the patient was provided with troubleshooting techniques to try in order to get the pump to depress.He stated he will contact bsc again if he has any further questions.The patient saw his physician in the office and the physician also found that he was not able to activate the pump following the implant surgery.

• 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: 10466836
• MDR Text Key: 204753393
• Report Number: 2183959-2020-03835
• Device Sequence Number: 1
• Product Code: FHW
• UDI-Device Identifier: 00878953003610
• UDI-Public: 00878953003610
• 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: 10/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2020
• Device Model Number: 72404253
• Device Catalogue Number: 72404253
• Device Lot Number: 1000183185
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Patient Sequence Number: 1
• Patient Age: 71 YR