MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS PENILE

Model Number	720056-03
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Discomfort (2330); Insufficient Information (4580)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number, manufacture date and expiration date were unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.
Event or Problem Description
It was reported, that the patient stated, that he can hear creaking of this spectra penile prosthesis.And in addition, he is experiencing discomfort and an increase of sensitivity in the region of the glans and perineum.Imaging tests were performed.During which, it was identified an asymmetry in the glans and a shortening with a fold in the perineum.A revision surgery has been requested.No additional information was reported.
Additional Manufacturer Narrative
The lot number, manufacture date and expiration date were unable to be obtained through good faith efforts.The data was obtained through a review of the surgical history previously provided by the physician.There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these device as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
Event or Problem Description
It was reported that the patient stated that he can hear creaking of this spectra penile prosthesis and, in addition, he is experiencing discomfort and an increase of sensitivity in the region of the glans and perineum.Imaging tests were performed, during which it was identified an asymmetry in the glans and a shortening with a fold in the perineum.The patient wants to change the existing device for a malleable one.A revision surgery has been requested.No additional information was reported.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Common Device Name: PROSTHESIS PENILE
• 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: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17301732
• Report Number: 2124215-2023-36324
• Device Sequence Number: 17089952
• Product Code: FAE
• UDI-Device Identifier: 00878953005256
• UDI-Public: 00878953005256
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090663
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/24/2021
• Device Model Number: 720056-03
• Device Catalogue Number: 720056-03
• Device Lot Number: 0137231003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown