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

Model Number	72404234
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had three penile implants and that the last one only lasted two years.He claims he was told the device would last ten years and wanted to know what the life span of the device was.He was informed that each device had a different life span for different patients and that it was a mechanical device so there is not a firm time frame on failure rates.We did go over the warranty policy.He asked what boston scientific is going to give him for his pain and suffering.I let him know that the warranty only covered the cost of the device at the time it was placed if the conditions of the warranty were met.Again, he asked for compensation for his pain and suffering.I let him know that i did not have any authority over financial decisions.He asked to speak to the legal department.

• 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: 8587419
• Report Number: 2183959-2019-62873
• Device Sequence Number: 19229163
• Product Code: FHW
• UDI-Device Identifier: 00878953003474
• UDI-Public: 00878953003474
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 07/27/2018
• Device Model Number: 72404234
• Device Catalogue Number: 72404234
• Device Lot Number: 0144746001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 66 YR