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

Model Number	72401458
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the complaint component was not returned for analysis, and the product record review revealed no additional information related to the complaint.An overall investigation conclusion code of no problem detected was chosen as the reported device problem cannot be confirmed.The reported allegations could not be confirmed.The event cannot be reproduced or substantiated; therefore, no escalation to ncep, capa, or scar is required.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to replace this ambicor penile prosthesis (app) due to sensitivity causing the pump to be too painful for the patient to operate.The app was removed and replaced with a malleable prosthesis.There were no patient complications.Product return is not expected, but should further information become available, bsc will submit a supplemental report with any new information.

• Brand Name: AMS AMBICOR PENILE PROSTHESIS
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 9111025
• Report Number: 2183959-2019-66365
• Device Sequence Number: 3174105
• Product Code: FHW
• UDI-Device Identifier: 00878953001029
• UDI-Public: 00878953001029
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/18/2023
• Device Model Number: 72401458
• Device Catalogue Number: 72401458
• Device Lot Number: 1000075053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 59 YR