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

Model Number	72404250
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient that this inflatable penile prosthesis (ipp) had not been functioning properly since implant.Troubleshooting techniques were provided by patient services (ps); however, the patient stated that he had tried them all without success.He also reported pain in the perineum and rectum and mentioned that he has been passing stones.The boston scientific ps representative encouraged him to get clinical evaluation.No further information was provided.
Additional Manufacturer Narrative
The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.Estimated to approximately six weeks post-implant, assumed time of device activation.

• Brand Name: AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE
• Common Device Name: DEVICE IMPOTENCE MECHANICAL/HYDRAULIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 15671555
• Report Number: 2124215-2022-43637
• Device Sequence Number: 6421604
• Product Code: FHW
• UDI-Device Identifier: 00878953003580
• UDI-Public: 00878953003580
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N970012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

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: 07/05/2018
• Device Model Number: 72404250
• Device Catalogue Number: 72404250
• Device Lot Number: 0142135001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RESERVOIR: 720185-01/1000022609
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Male