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

Model Number	72404255
Medical Device Problem Codes	Defective Device (2588); Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reservoir 65 ml pc/iz.Device impotence mechanical/hydraulic.
Event or Problem Description
It was reported that patient had inflatable penile prosthesis (ipp) implanted over 10 years ago, post radical prostatectomy for cancer.Over the last 8-9 months, he noted pain whenever he sat down.Examination revealed the device had migrated out of position.The device was removed and a new one implanted.No signs of infection noted at the time of surgery.The surgeon described in his operative report that the old implant had "ridden up on the right side over the pubic bone." what problem did the user have: device malfunction - that is, the device did not do what it was supposed to do.Other information about the patient that may have influenced the outcome of the event: possible age and previous surgical intervention.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8842970
• Report Number: 2183959-2019-65386
• Device Sequence Number: 3294978
• Product Code: FHW
• UDI-Device Identifier: 00878953003634
• UDI-Public: 00878953003634
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/18/2010
• Device Model Number: 72404255
• Device Catalogue Number: 72404255
• Device Lot Number: 551475004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 84