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

Model Number 720056-03

Device Problem Noise, Audible (3273)

Patient Problems Hypersensitivity/Allergic reaction (1907); Discomfort (2330); Insufficient Information (4580)

Event Date 06/14/2023

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 318862039
• Report Number: 2124215-2023-36324
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 00878953005256
• UDI-Public: 00878953005256
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K090663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other