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

Model Number	72404241
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number: 72404241, lot number: 0160822002, model description: lgx 12cm snap fit rt iz.Model number: 72404155, lot number: 1000135232, model description: reservoir 65 ml pc/iz.
Event or Problem Description
It was reported that the patient underwent a surgical procedure to replace this inflatable penile prosthesis (ipp) for unspecified reasons.The existing device was removed and a new ipp was implanted.There were no patient complications reported.The explanted components are not expected for return.No further information is available at this time.Additional information was received indicating the procedure was performed as the pump ceased to function after several months of implant.During the procedure the physician noted the pump could not be activated; the cause of the issue could not be determined.

• 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: 9099372
• Report Number: 2183959-2019-66316
• Device Sequence Number: 2656898
• Product Code: FHW
• UDI-Device Identifier: 00878953003535
• UDI-Public: 00878953003535
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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: 01/11/2019
• Device Model Number: 72404241
• Device Catalogue Number: 72404241
• Device Lot Number: 0160822002
• 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: 09/20/2019
• 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: 57 YR