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

Model Number	72401453
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced unspecified issues with an ambicor penile prosthesis (app).The app was explanted and a new 15cm inflatable penile prosthesis (ipp) was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.
Event or Problem Description
It was reported that the patient experienced unspecified issues with an ambicro penile prosthesis (app).The app was explanted and a new 15cm inflatable penile prosthesis (ipp) was implanted.Further information has been requested and not yet received.Should additional relevant details become available or the product was returned, a supplemental report will be submitted upon completion of product analysis.Additional information was reported that the ambicor was explanted prior to the new ipp implant and the patient did not have any device implanted at time of revision.

• 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: 8396728
• Report Number: 2183959-2019-61363
• Device Sequence Number: 11510471
• Product Code: FHW
• UDI-Device Identifier: 00878953000978
• UDI-Public: 00878953000978
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 10/05/2005
• Device Model Number: 72401453
• Device Catalogue Number: 72401453
• Device Lot Number: 311742001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention