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

Device Problem Failure to Cycle (1142)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2020

Event Type  Injury  

Event Description

It was reported that the patient experienced a removal of an inflatable penile prosthesis(ipp) device due to the ipp not cycling properly.A patient outcome was not reported.

Manufacturer Narrative

Additional information received that the patient outcome was reported to be good.

Event Description

It was reported that the patient experienced a removal of an inflatable penile prosthesis(ipp) device due to the ipp not cycling properly.A patient outcome was not reported.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS
• Type of Device: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 10330724
• MDR Text Key: 200589700
• Report Number: 2183959-2020-03225
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 08/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 73 YR