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

Model Number	72401453
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that patient liaison spoke with patient who had an ambicor penile prosthesis (app) implanted 3 months ago.He has been unhappy since the implant for two main reasons: he says it shanks so severely to the left that when he urinates, if he does not control it, he pees all over.It does not measure what he did when he used the vacuum pump prior to surgery.Patient liaison explained him that the pump pulled blood flow into areas that our device does not address and that could be the size difference that he is noticing.He asked for assistance in finding a doctor for a second opinion; patient liaison gave him the two names that populated on (b)(6) that were closest to his zip code.He requested to speak with the rep.And patient liaison sent the information to the bsc rep.Additional information was requested, however no further information was available.

• 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: 9249598
• Report Number: 2183959-2019-67134
• Device Sequence Number: 2352251
• Product Code: FHW
• UDI-Device Identifier: 00878953000978
• UDI-Public: 00878953000978
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/27/2024
• Device Model Number: 72401453
• Device Catalogue Number: 72401453
• Device Lot Number: 1000268002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1
• Patient Age: 75 YR