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

Model Number	72404283
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	03/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related components: model 72404162, lot 831721003.Model 72401850, lot 111675009.
Event or Problem Description
It was reported that the patient is experiencing dissatisfactory results with his inflatable penile prosthesis(ipp) device.The patient was seen in (b)(6) 2019 and tests of erection and inflation of the prosthesis were performed and at the time it was identified that the device only partially fills and shows a defect.The patient is still dissatisfied and reports that his penis is swollen and in pain and suspects the migration of the ipp.The patient is requesting a replacement of an ipp for an ambicor penile prosthesis(app) and the revision is approved by the physician.

• Brand Name: AMS INFLATABLE 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: 10304870
• Report Number: 2183959-2020-03093
• Device Sequence Number: 16839168
• Product Code: FHW
• UDI-Device Identifier: 00878953003863
• UDI-Public: 00878953003863
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/29/2019
• Device Model Number: 72404283
• Device Catalogue Number: 72404283
• Device Lot Number: 868419002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR